T Acute Lymphoblastic LeukemiaPhase 2DARA_T_ALLNCT07021677
Use of a New Medicine "Daratumumab" to Treat Left-over Cancer in a Blood Cancer Called "T Acute Lymphoblastic Leukemia"
A Phase 2 study testing Daratumumab Injection in people with T Acute Lymphoblastic Leukemia, run by Tata Memorial Centre at 1 site in India.
Trial summary
T-ALL (T-acute lymphoblastic leukemia) is an aggressive blood cancer, wherein patients who are MRD positive after two courses of induction chemotherapy have poor outcomes. This goal of this study is to determine if Daratumumab can make such T-ALL patients MRD negative. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- T Acute Lymphoblastic Leukemia
- What is being tested?
- Daratumumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteIndia
- Study dates
- 28 Aug 2023to 28 Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 - ≤65 years of age
- Baseline diagnosis of T-ALL, including ETP-ALL
- MRD positive (≥0.01%) disease (by flow-cytometry) assessed on BM after two phases of induction chemotherapy in CR-1
- CD38 positive
- Eastern cooperative oncology group (ECOG) performance status ≤2
- Acceptable liver functions, as specified below:
Show all 9Show fewer
- Total bilirubin <2 times upper limit of normal (ULN); Aspartate transaminase (AST;SGOT), alanine transaminase (ALT;SGPT) <3 ULN
- Subject ready to sign an informed consent form
- Patients with baseline CSF cytology positive, but who have cleared CSF by either modality (cytology or flow cytometry)
Who cannot join
- T-LBL (T-lymphoblastic lymphoma) without BM involvement
- Patients with persistently positive CSF cytology after two phases of induction or baseline testicular involvement
- Patients with symptomatic obstructive airway disease, as per assessing clinician
- Presence of an active systemic infection, as per assessing clinician
- New York Heart Association (NYHA) Class III or IV cardiac disease, or left ventricular ejection fraction <40%
- Human immunodeficiency virus (HIV) positive.
- Pregnant or breastfeeding female
- HBsAg positive or HBV-DNA positivity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Dr.Sumeet Mirgh
Navi Mumbai, Maharashtra, 410210
Sumeet Mirgh, MD, DM, 91-8130140245, drsumeetmirgh@gmail.com
Anant Gokarn, MD, DM, 91-8097295540, anantgokarn@gmail.com
About this study
Official title: Daratumumab for Minimal Residual Disease Eradication in T-Acute Lymphoblastic Leukemia - A Phase 2 Study
T-ALL (T-acute lymphoblastic leukemia) is an aggressive blood cancer, wherein patients who are MRD positive after two courses of induction chemotherapy have poor outcomes. This goal of this study is to determine if Daratumumab can make such T-ALL patients MRD negative.
The main questions this study aims to answer are -
Read more
- Whether MRD Positive T-ALL patients can become MRD negative after two doses of daratumumab?
- Whether MRD Positive T-ALL patients can become MRD negative after four doses of daratumumab?
- Whether addition of daratumumab can affect the risk of progression or death at 1-year?
- Whether daratumumab is safe to use?
Newly diagnosed patients of T-ALL who are MRD positive after two courses of induction chemotherapy will be eligible to receive daratumumab. These patients will receive two doses of weekly intravenous daratumumab at standard dose (16mg/kg), and will undergo repeat evaluation of MRD from bone marrow one week after the second dose of daratumumab. Patients who become MRD negative will continue chemotherapy as per institutional policy. Those who remain MRD positive will be eligible to receive two additional doses, and will undergo another bone marrow MRD testing one week after the fourth dose. Irrespective of the results after the fourth dose, patients will be continued on chemotherapy as per institutional policy.
Read the detailed description
Hypothesis - Daratumumab will increase the MRD negative CR rate in newly diagnosed T-ALL who are MRD positive after two-cycles of induction chemotherapy.
Rationale of dosing Daratumumab being a monoclonal antibody primarily depends on its target mediated clearance. In myeloma, dose finding studies of daratumumab showed that the drug at a dose of 16mg per kg was able to saturate all the receptors due to which a lower clearance and higher trough concentrations were observed. On the other hand, a lower dose of 8 mg/kg demonstrated higher clearance due to lack of complete target engagement / saturation. Hence, 16 mg/kg was the approved dose. In accordance with the above concept, daratumumab has been used in multiple indications apart from myeloma viz. PRCA post-transplant, Extranodal NK/T lymphoma, Blastic Plasmacytoid Dendritic Cell Neoplasm, at the myeloma approved dose of 16 mg/kg. Moreover, from its phenomenon of indirect coombs test positivity, it is evident that daratumumab binds CD38 antigen on RBCs, even though the expression of CD38 on RBCs is low. Its ability to bind to CD38 antigen across cell lineages, further supports that the same dose will be valid for T-ALL.
Method - T-ALL adult patients (on modified BFM-90 induction chemotherapy or any other pediatric inspired protocol) who are MRD positive by flow cytometry (≥0.01%) at end of phase 1a induction, will undergo a bone marrow-minimal residual disease (BM-MRD) testing at the end of phase 1b induction (or after 2 phases of induction of any pediatric inspired protocol), at count recovery (ANC>1000/cumm, Platelet >75,000/cumm).
Multicolor flow-cytometry for MRD will be performed using a 13-color T-MRD panel in Dx FLEX flow-cytometer (Beckman Coulter). The analysis will be performed with Kaluza version 2.0 software.
T-ALL patients in CR-1 who are MRD positive i.e., ≥0.01% on flow-cytometry at the end of phase 1b induction (two phases of chemotherapy) and CD38 positive (expression on >=20% blasts) will be eligible for the study
Study schema MRD positive patients of T-ALL who fulfil criteria as mentioned above will be enrolled in the study. Before starting daratumumab, investigations will be performed as mentioned below. First dose of daratumumab will be administered as an in-patient for 24 hours, as per protocol mentioned below. Those who tolerate daratumumab well i.e., not more than grade 1 infusion related reaction (IRR) will be given subsequent doses on out-patient basis in day-care. BM aspirate for MRD analysis will be done 7days (± 2days) after second dose of daratumumab. Those who become MRD negative (<0.01% by flow-cytometry), will be off-study and continued on conventional treatment regimen as per institution policy. Those who are still MRD positive (≥0.01% by flow-cytometry) after two doses, will be given two additional weekly doses of daratumumab. In patients who receive two additional doses, BM aspirate for MRD analysis will be done 7days (± 2days) after fourth dose of daratumumab. Irrespective of MRD result after fourth dose, patients will be continued on conventional treatment regimen as per institution policy. Last follow-up time point for SAE related to intervention will be four weeks after last dose of daratumumab.
- Conditions
- T Acute Lymphoblastic Leukemia
- Being tested
- Daratumumab Injection
- Keywords
- daratumumab, T-Acute lymphoblastic leukemia, minimal residual disease, MRD, Post induction MRD
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daratumumab InjectionDrug
Also called Darzalex
Patients will receive intravenous daratumumab (16mg/kg per dose) once weekly for 2 doses. After 2 doses, they will undergo bone marrow examination for flow-cytometric MRD. Those who become MRD negative (less than 0.01% by flow-cytometry), will be off-study and continued on conventional treatment regimen as per institution policy. Hence, total duration in those who become MRD negative will be 3 weeks.
However, those who are still MRD positive (more than or equal to 0.01% by flowcytometry) after two doses, will be given two additional once weekly doses of intravenous daratumumab (16mg/kg per dose). In patients who receive two additional doses, bone marrow aspirate for MRD analysis will be done 7 days after fourth dose of daratumumab. Irrespective of MRD result after fourth dose, patients will be continued on conventional treatment regimen
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | This will be a single arm, open-label, prospective, interventional phase 2 study. T-ALL patients who are MRD positive post two courses of induction therapy (as per pediatric inspired protocol) will be eligible for this study Receives: Drug: Daratumumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRD negativity
To determine the MRD negativity rates after two doses of weekly intravenous daratumumab as a single agent for MRD positive T-ALL
Measured: "week 3 after Daratumumab initiation"
Secondary outcomes (3)
To determine cumulative incidence of MRD negativity
To determine cumulative incidence of MRD negativity with upto 4 doses of daratumumab monotherapy
Measured: "Upto week 5 after Daratumumab initiation"
Progression free survival
To determine progression free survival at 1 year
Measured: "1-year after initiation of daratumumab"
Adverse events
To determine incidence of adverse events (as per CTCAE v5.0 2017) after daratumumab therapy
Measured: "From day of initiation of daratumumab till four weeks after the last dose of daratumumab"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start28 Aug 2023
- Primary completion28 Aug 2026 (estimated)
- Study completion28 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for T Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intravenous daratumumab (16mg/kg per dose) once weekly for 2 doses. After 2 doses, they will undergo bone marrow examination for flow-cytometric MRD. Those who become MRD negative (less than 0.01% by flow-cytometry), will be off-study and continued on conventional treatment regimen as per institution policy. Hence, total duration in those who become MRD negative will be 3 weeks. However, those who are still MRD positive (more than or equal to 0.01% by flowcytometry) after two doses, will be given two additional once weekly doses of intravenous daratumumab (16mg/kg per dose). In patients who receive two additional doses, bone marrow aspirate for MRD analysis will be done 7 days after fourth dose of daratumumab. Irrespective of MRD result after fourth dose, patients will be continued on conventional treatment regimen
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumeet Mirgh, MD, DM, Principal investigator, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Tata Memorial Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021677
- Sponsor's protocol ID
- 900938
- Acronym
- DARA_T_ALL
- Status last verified
- Jun 2025
- First submitted
- 6 Oct 2023
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD details will not be shared for maintaining patients confidentiality
Publications
Usmani SZ, Weiss BM, Plesner T, Bahlis NJ, Belch A, Lonial S, Lokhorst HM, Voorhees PM, Richardson PG, Chari A, Sasser AK, Axel A, Feng H, Uhlar CM, Wang J, Khan I, Ahmadi T, Nahi H. Clinical efficacy of daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma. Blood. 2016 Jul 7;128(1):37-44. doi: 10.1182/blood-2016-03-705210. Epub 2016 May 23.
PubMed 27216216Lokhorst HM, Plesner T, Laubach JP, Nahi H, Gimsing P, Hansson M, Minnema MC, Lassen U, Krejcik J, Palumbo A, van de Donk NW, Ahmadi T, Khan I, Uhlar CM, Wang J, Sasser AK, Losic N, Lisby S, Basse L, Brun N, Richardson PG. Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma. N Engl J Med. 2015 Sep 24;373(13):1207-19. doi: 10.1056/NEJMoa1506348. Epub 2015 Aug 26.
PubMed 26308596Lancman G, Arinsburg S, Jhang J, Cho HJ, Jagannath S, Madduri D, Parekh S, Richter J, Chari A. Blood Transfusion Management for Patients Treated With Anti-CD38 Monoclonal Antibodies. Front Immunol. 2018 Nov 15;9:2616. doi: 10.3389/fimmu.2018.02616. eCollection 2018.
PubMed 30498492Blair HA. Daratumumab: A Review in Relapsed and/or Refractory Multiple Myeloma. Drugs. 2017 Dec;77(18):2013-2024. doi: 10.1007/s40265-017-0837-7.
PubMed 29127588Michaleas S, Penninga E, Hovgaard D, Dalseg AM, Rosso A, Sarac SB, Jimenez JC, Fernandez LL, Fernandez CP, Mangas-SanJuan V, Garcia I, Payares-Herrera C, Sancho-Lopez A, Enzmann H, de Castro Lopes Silva MSS, Duarte S, Pignatti F. EMA Review of Daratumumab (Darzalex) for the Treatment of Adult Patients Newly Diagnosed with Multiple Myeloma. Oncologist. 2020 Dec;25(12):1067-1074. doi: 10.1002/onco.13554. Epub 2020 Oct 16.
PubMed 33026700Mirgh S, Sharma A, Folbs B, Khushoo V, Kapoor J, Tejwani N, Ahmed R, Agrawal N, Choudhary PS, Mehta P, Bhurani D. Daratumumab-based therapy after prior Azacytidine-Venetoclax in an octagenerian female with BPDCN (blastic plasmacytoid dendritic cell neoplasm) - a new perspective. Leuk Lymphoma. 2021 Dec;62(12):3039-3042. doi: 10.1080/10428194.2021.1941938. Epub 2021 Jun 21. No abstract available.
PubMed 34151693Huang H, Zhu J, Yao M, Kim TM, Yoon DH, Cho SG, Eom HS, Lim ST, Yeh SP, Song Y, Kwong YL, Kim JS, Jin J, Shi Y, Kim H, Qing M, Zhou T, Gao G, Dong Z, Qi M, Kim WS. Daratumumab monotherapy for patients with relapsed or refractory natural killer/T-cell lymphoma, nasal type: an open-label, single-arm, multicenter, phase 2 study. J Hematol Oncol. 2021 Feb 15;14(1):25. doi: 10.1186/s13045-020-01020-y.
PubMed 33588922Jeyaraman P, Borah P, Rajput P, Dayal N, Pathak S, Naithani R. Daratumumab for pure red cell aplasia post ABO incompatible allogeneic hematopoietic stem cell transplant for aplastic anemia. Blood Cells Mol Dis. 2021 May;88:102464. doi: 10.1016/j.bcmd.2020.102464. Epub 2020 Jul 2.
PubMed 32653327Palladini G, Kastritis E, Maurer MS, Zonder J, Minnema MC, Wechalekar AD, Jaccard A, Lee HC, Bumma N, Kaufman JL, Medvedova E, Kovacsovics T, Rosenzweig M, Sanchorawala V, Qin X, Vasey SY, Weiss BM, Vermeulen J, Merlini G, Comenzo RL. Daratumumab plus CyBorD for patients with newly diagnosed AL amyloidosis: safety run-in results of ANDROMEDA. Blood. 2020 Jul 2;136(1):71-80. doi: 10.1182/blood.2019004460.
PubMed 32244252Cerrano M, Bonifacio M, Olivi M, Curti A, Malagola M, Dargenio M, Scattolin AM, Papayannidis C, Forghieri F, Gurrieri C, Tanasi I, Zappasodi P, La Starza R, Fracchiolla NS, Chiusolo P, Giaccone L, Del Principe MI, Giglio F, Defina M, Favre C, Rizzari C, Castella B, Pizzolo G, Ferrara F, Chiaretti S, Foa R. Daratumumab with or without chemotherapy in relapsed and refractory acute lymphoblastic leukemia. A retrospective observational Campus ALL study. Haematologica. 2022 Apr 1;107(4):996-999. doi: 10.3324/haematol.2021.279851. No abstract available.
PubMed 35021604Punatar S, Gokarn A, Nayak L, Bonda A, Chichra A, Mirgh S, Bagal B, Tembhare P, Subramanian P, Khattry N. Long term outcome of a patient with relapsed refractory early thymic precursor acute lymphoblastic leukemia treated with daratumumab. Am J Blood Res. 2021 Oct 15;11(5):528-533. eCollection 2021.
PubMed 34824885Li Z et al. Daratumumab regimen in treatment of relapsed hematological malignancies in children after allo-HSCT. APBMT 2020 (Oral-535)
Brammer JE, Saliba RM, Jorgensen JL, Ledesma C, Gaballa S, Poon M, Maziarz RT, Champlin RE, Hosing C, Kebriaei P. Multi-center analysis of the effect of T-cell acute lymphoblastic leukemia subtype and minimal residual disease on allogeneic stem cell transplantation outcomes. Bone Marrow Transplant. 2017 Jan;52(1):20-27. doi: 10.1038/bmt.2016.194. Epub 2016 Sep 12.
PubMed 27618682Shen Z, Gu X, Mao W, Yin L, Yang L, Zhang Z, Liu K, Wang L, Huang Y. Influence of pre-transplant minimal residual disease on prognosis after Allo-SCT for patients with acute lymphoblastic leukemia: systematic review and meta-analysis. BMC Cancer. 2018 Jul 23;18(1):755. doi: 10.1186/s12885-018-4670-5.
PubMed 30037340Rajendra A, Jain H, Bonda VNA, Nayak L, Tembhare P, Shetty D, Thorat J, Jain H, Subramanian PG, Patkar N, Chatterjee G, Khattry N, Gokarn A, Punatar S, Mokal S, Bagal B, Sengar M. Outcomes and prognostic factors in adolescents and young adults with ALL treated with a modified BFM-90 protocol. Blood Adv. 2021 Mar 9;5(5):1178-1193. doi: 10.1182/bloodadvances.2020003526.
PubMed 33635331
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daratumumab for Minimal Residual Disease Eradication in T-Acute Lymphoblastic Leukemia - A Phase 2 Study
- ClinicalTrials.gov ID
- NCT07021677
- Acronym / sponsor ID
- DARA_T_ALL / 900938
- Conditions
- T Acute Lymphoblastic Leukemia
- Keywords
- daratumumab, T-Acute lymphoblastic leukemia, minimal residual disease, MRD, Post induction MRD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 28 Aug 2026 (estimated)
- Study completion
- 28 Aug 2026 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
T-ALL (T-acute lymphoblastic leukemia) is an aggressive blood cancer, wherein patients who are MRD positive after two courses of induction chemotherapy have poor outcomes. This goal of this study is to determine if Daratumumab can make such T-ALL patients MRD negative.
The main questions this study aims to answer are -
- Whether MRD Positive T-ALL patients can become MRD negative after two doses of daratumumab?
- Whether MRD Positive T-ALL patients can become MRD negative after four doses of daratumumab?
- Whether addition of daratumumab can affect the risk of progression or death at 1-year?
- Whether daratumumab is safe to use?
Newly diagnosed patients of T-ALL who are MRD positive after two courses of induction chemotherapy will be eligible to receive daratumumab. These patients will receive two doses of weekly intravenous daratumumab at standard dose (16mg/kg), and will undergo repeat evaluation of MRD from bone marrow one week after the second dose of daratumumab. Patients who become MRD negative will continue chemotherapy as per institutional policy. Those who remain MRD positive will be eligible to receive two additional doses, and will undergo another bone marrow MRD testing one week after the fourth dose. Irrespective of the results after the fourth dose, patients will be continued on chemotherapy as per institutional policy.
Detailed description
Hypothesis - Daratumumab will increase the MRD negative CR rate in newly diagnosed T-ALL who are MRD positive after two-cycles of induction chemotherapy.
Rationale of dosing Daratumumab being a monoclonal antibody primarily depends on its target mediated clearance. In myeloma, dose finding studies of daratumumab showed that the drug at a dose of 16mg per kg was able to saturate all the receptors due to which a lower clearance and higher trough concentrations were observed. On the other hand, a lower dose of 8 mg/kg demonstrated higher clearance due to lack of complete target engagement / saturation. Hence, 16 mg/kg was the approved dose. In accordance with the above concept, daratumumab has been used in multiple indications apart from myeloma viz. PRCA post-transplant, Extranodal NK/T lymphoma, Blastic Plasmacytoid Dendritic Cell Neoplasm, at the myeloma approved dose of 16 mg/kg. Moreover, from its phenomenon of indirect coombs test positivity, it is evident that daratumumab binds CD38 antigen on RBCs, even though the expression of CD38 on RBCs is low. Its ability to bind to CD38 antigen across cell lineages, further supports that the same dose will be valid for T-ALL.
Method - T-ALL adult patients (on modified BFM-90 induction chemotherapy or any other pediatric inspired protocol) who are MRD positive by flow cytometry (≥0.01%) at end of phase 1a induction, will undergo a bone marrow-minimal residual disease (BM-MRD) testing at the end of phase 1b induction (or after 2 phases of induction of any pediatric inspired protocol), at count recovery (ANC>1000/cumm, Platelet >75,000/cumm).
Multicolor flow-cytometry for MRD will be performed using a 13-color T-MRD panel in Dx FLEX flow-cytometer (Beckman Coulter). The analysis will be performed with Kaluza version 2.0 software.
T-ALL patients in CR-1 who are MRD positive i.e., ≥0.01% on flow-cytometry at the end of phase 1b induction (two phases of chemotherapy) and CD38 positive (expression on >=20% blasts) will be eligible for the study
Study schema MRD positive patients of T-ALL who fulfil criteria as mentioned above will be enrolled in the study. Before starting daratumumab, investigations will be performed as mentioned below. First dose of daratumumab will be administered as an in-patient for 24 hours, as per protocol mentioned below. Those who tolerate daratumumab well i.e., not more than grade 1 infusion related reaction (IRR) will be given subsequent doses on out-patient basis in day-care. BM aspirate for MRD analysis will be done 7days (± 2days) after second dose of daratumumab. Those who become MRD negative (<0.01% by flow-cytometry), will be off-study and continued on conventional treatment regimen as per institution policy. Those who are still MRD positive (≥0.01% by flow-cytometry) after two doses, will be given two additional weekly doses of daratumumab. In patients who receive two additional doses, BM aspirate for MRD analysis will be done 7days (± 2days) after fourth dose of daratumumab. Irrespective of MRD result after fourth dose, patients will be continued on conventional treatment regimen as per institution policy. Last follow-up time point for SAE related to intervention will be four weeks after last dose of daratumumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intravenous daratumumab (16mg/kg per dose) once weekly for 2 doses. After 2 doses, they will undergo bone marrow examination for flow-cytometric MRD. Those who become MRD negative (less than 0.01% by flow-cytometry), will be off-study and continued on conventional treatment regimen as per institution policy. Hence, total duration in those who become MRD negative will be 3 weeks. However, those who are still MRD positive (more than or equal to 0.01% by flowcytometry) after two doses, will be given two additional once weekly doses of intravenous daratumumab (16mg/kg per dose). In patients who receive two additional doses, bone marrow aspirate for MRD analysis will be done 7 days after fourth dose of daratumumab. Irrespective of MRD result after fourth dose, patients will be continued on conventional treatment regimen
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Drug: Daratumumab InjectionThis will be a single arm, open-label, prospective, interventional phase 2 study. T-ALL patients who are MRD positive post two courses of induction therapy (as per pediatric inspired protocol) will be eligible for this study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults ≥18 - ≤65 years of age
- Baseline diagnosis of T-ALL, including ETP-ALL
- MRD positive (≥0.01%) disease (by flow-cytometry) assessed on BM after two phases of induction chemotherapy in CR-1
- CD38 positive
- Eastern cooperative oncology group (ECOG) performance status ≤2
Key exclusion criteria (8 listed)
- T-LBL (T-lymphoblastic lymphoma) without BM involvement
- Patients with persistently positive CSF cytology after two phases of induction or baseline testicular involvement
- Patients with symptomatic obstructive airway disease, as per assessing clinician
- Presence of an active systemic infection, as per assessing clinician
- New York Heart Association (NYHA) Class III or IV cardiac disease, or left ventricular ejection fraction <40%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daratumumab InjectionAlso: DarzalexPatients will receive intravenous daratumumab (16mg/kg per dose) once weekly for 2 doses. After 2 doses, they will undergo bone marrow examination for flow-cytometric MRD. Those who become MRD negative (less than 0.01% by flow-cytometry), will be off-study and continued on conventional treatment regimen as per institution policy. Hence, total duration in those who become MRD negative will be 3 weeks. However, those who are still MRD positive (more than or equal to 0.01% by flowcytometry) after two doses, will be given two additional once weekly doses of intravenous daratumumab (16mg/kg per dose). In patients who receive two additional doses, bone marrow aspirate for MRD analysis will be done 7 days after fourth dose of daratumumab. Irrespective of MRD result after fourth dose, patients will be continued on conventional treatment regimen | Drug | Single Arm |
Primary outcome
MRD negativity
Time frame: "week 3 after Daratumumab initiation"
To determine the MRD negativity rates after two doses of weekly intravenous daratumumab as a single agent for MRD positive T-ALL
3 secondary outcomes
To determine cumulative incidence of MRD negativity
Time frame: "Upto week 5 after Daratumumab initiation"
Progression free survival
Time frame: "1-year after initiation of daratumumab"
Adverse events
Time frame: "From day of initiation of daratumumab till four weeks after the last dose of daratumumab"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Results publication: PubMed 27216216Usmani SZ, Weiss BM, Plesner T, Bahlis NJ, Belch A, Lonial S, Lokhorst HM, Voorhees PM, Richardson PG, Chari A, Sasser AK, Axel A, Feng H, Uhlar CM, Wang J, Khan I, Ahmadi T, Nahi H. Clinical efficacy of daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma. Blood. 2016 Jul 7;128(1):37-44. doi: 10.1182/blood-2016-03-705210. Epub 2016 May 23.
- Results publication: PubMed 26308596Lokhorst HM, Plesner T, Laubach JP, Nahi H, Gimsing P, Hansson M, Minnema MC, Lassen U, Krejcik J, Palumbo A, van de Donk NW, Ahmadi T, Khan I, Uhlar CM, Wang J, Sasser AK, Losic N, Lisby S, Basse L, Brun N, Richardson PG. Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma. N Engl J Med. 2015 Sep 24;373(13):1207-19. doi: 10.1056/NEJMoa1506348. Epub 2015 Aug 26.
- Results publication: PubMed 30498492Lancman G, Arinsburg S, Jhang J, Cho HJ, Jagannath S, Madduri D, Parekh S, Richter J, Chari A. Blood Transfusion Management for Patients Treated With Anti-CD38 Monoclonal Antibodies. Front Immunol. 2018 Nov 15;9:2616. doi: 10.3389/fimmu.2018.02616. eCollection 2018.
- Results publication: PubMed 29127588Blair HA. Daratumumab: A Review in Relapsed and/or Refractory Multiple Myeloma. Drugs. 2017 Dec;77(18):2013-2024. doi: 10.1007/s40265-017-0837-7.
- Results publication: PubMed 33026700Michaleas S, Penninga E, Hovgaard D, Dalseg AM, Rosso A, Sarac SB, Jimenez JC, Fernandez LL, Fernandez CP, Mangas-SanJuan V, Garcia I, Payares-Herrera C, Sancho-Lopez A, Enzmann H, de Castro Lopes Silva MSS, Duarte S, Pignatti F. EMA Review of Daratumumab (Darzalex) for the Treatment of Adult Patients Newly Diagnosed with Multiple Myeloma. Oncologist. 2020 Dec;25(12):1067-1074. doi: 10.1002/onco.13554. Epub 2020 Oct 16.
- Results publication: PubMed 34151693Mirgh S, Sharma A, Folbs B, Khushoo V, Kapoor J, Tejwani N, Ahmed R, Agrawal N, Choudhary PS, Mehta P, Bhurani D. Daratumumab-based therapy after prior Azacytidine-Venetoclax in an octagenerian female with BPDCN (blastic plasmacytoid dendritic cell neoplasm) - a new perspective. Leuk Lymphoma. 2021 Dec;62(12):3039-3042. doi: 10.1080/10428194.2021.1941938. Epub 2021 Jun 21. No abstract available.
- Results publication: PubMed 33588922Huang H, Zhu J, Yao M, Kim TM, Yoon DH, Cho SG, Eom HS, Lim ST, Yeh SP, Song Y, Kwong YL, Kim JS, Jin J, Shi Y, Kim H, Qing M, Zhou T, Gao G, Dong Z, Qi M, Kim WS. Daratumumab monotherapy for patients with relapsed or refractory natural killer/T-cell lymphoma, nasal type: an open-label, single-arm, multicenter, phase 2 study. J Hematol Oncol. 2021 Feb 15;14(1):25. doi: 10.1186/s13045-020-01020-y.
- Results publication: PubMed 32653327Jeyaraman P, Borah P, Rajput P, Dayal N, Pathak S, Naithani R. Daratumumab for pure red cell aplasia post ABO incompatible allogeneic hematopoietic stem cell transplant for aplastic anemia. Blood Cells Mol Dis. 2021 May;88:102464. doi: 10.1016/j.bcmd.2020.102464. Epub 2020 Jul 2.
- Results publication: PubMed 32244252Palladini G, Kastritis E, Maurer MS, Zonder J, Minnema MC, Wechalekar AD, Jaccard A, Lee HC, Bumma N, Kaufman JL, Medvedova E, Kovacsovics T, Rosenzweig M, Sanchorawala V, Qin X, Vasey SY, Weiss BM, Vermeulen J, Merlini G, Comenzo RL. Daratumumab plus CyBorD for patients with newly diagnosed AL amyloidosis: safety run-in results of ANDROMEDA. Blood. 2020 Jul 2;136(1):71-80. doi: 10.1182/blood.2019004460.
- Results publication: PubMed 35021604Cerrano M, Bonifacio M, Olivi M, Curti A, Malagola M, Dargenio M, Scattolin AM, Papayannidis C, Forghieri F, Gurrieri C, Tanasi I, Zappasodi P, La Starza R, Fracchiolla NS, Chiusolo P, Giaccone L, Del Principe MI, Giglio F, Defina M, Favre C, Rizzari C, Castella B, Pizzolo G, Ferrara F, Chiaretti S, Foa R. Daratumumab with or without chemotherapy in relapsed and refractory acute lymphoblastic leukemia. A retrospective observational Campus ALL study. Haematologica. 2022 Apr 1;107(4):996-999. doi: 10.3324/haematol.2021.279851. No abstract available.
- Results publication: PubMed 34824885Punatar S, Gokarn A, Nayak L, Bonda A, Chichra A, Mirgh S, Bagal B, Tembhare P, Subramanian P, Khattry N. Long term outcome of a patient with relapsed refractory early thymic precursor acute lymphoblastic leukemia treated with daratumumab. Am J Blood Res. 2021 Oct 15;11(5):528-533. eCollection 2021.
- Results publicationLi Z et al. Daratumumab regimen in treatment of relapsed hematological malignancies in children after allo-HSCT. APBMT 2020 (Oral-535)
- Individual participant dataSharing planned: No. IPD details will not be shared for maintaining patients confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sumeet Mirgh, MD, DM principal investigator
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Tata Memorial Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daratumumab Injection in people with T Acute Lymphoblastic Leukemia, run by Tata Memorial Centre at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sumeet Mirgh, MD, DM (91-8130140245, drsumeetmirgh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRD negativity (time frame: "week 3 after Daratumumab initiation"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07021677, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.