Acute Lymphoblastic LeukemiaPhase 2NCT03856216
Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation
A Phase 2 study testing Allogeneic Bone Marrow Transplantation, Bendamustine and Filgrastim-sndz in people with Acute Lymphoblastic Leukemia and B Acute Lymphoblastic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this phase II clinical study is to learn about the safety of inotuzumab ozogamicin when given with fludarabine, with or without bendamustine, melphalan, and rituximab before and after a stem cell transplant. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, Lymphocytic Neoplasm
- What is being tested?
- Allogeneic Bone Marrow Transplantation, Bendamustine and Filgrastim-sndz
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2019to 13 Oct 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants age 12 to 75.
- English and non-English speaking participants are eligible.
- CD22+ lymphoid malignancies including B-ALL
- Eligible to receive a reduced-intensity alloSCT
- Participants with:
- Indolent lymphoma participants who failed conventional treatment; or,
Show all 16Show fewer
- Acute lymphoblastic leukemia (ALL), aggressive lymphoma, indolent lymphoma in transformation, or those who have failed ≥ three small molecule inhibitors
- Donor: HLA compatible (8/8 match) related or matched unrelated donor (HLA-A, B, C, DRB1) or mismatched MUD (7/8 match) or haploidentical
- Performance status of 0 to 2, Lansky ≥ 80 for < 16 years and Karnofsky ≥ 80 for ≥ 16 years of age.
- Adequate organ function at time of study entry
- Creatinine less than or equal to 1.6 mg/dL
- Bilirubin less than 1.6 mg/dL
- SGPT < 2 x UL
- Ejection fraction >/= 40%
- FEV1, FVC and cDLCO >/= 40%
- Negative Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast-feeding. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
Who cannot join
- Human immunodeficiency virus (HIV) positive.
- Prior autologous transplant less than 1 year prior to consent.
- Active and uncontrolled disease/infection.
- Unable or unwilling to sign consent.
- Current active hepatic or biliary disease (with exception of Gilbert's syndrome).
- Active hepatitis B or C.
Show all 12Show fewer
- Recent systemic chemotherapy or radiation within 3 weeks of study entry (intrathecal therapy is allowed).
- Standard biological agents such as rituximab, TKIs such as ibrutinib and venetoclax are allowed to be given within 3 days prior to receiving inotuzumab ozogamicin. Blinatumomab is allowed to be given until 1 week prior to Day -13 inotuzumab ozogamicin on study.
- Prior inotuzumab ozogamicin within 3 weeks of study entry.
- Peripheral blast count of greater than 10 K/mL.
- QTcF interval > 470 ms.
- Participants with cognitive impairments and/or any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with obtaining informed consent or compliance with study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addition of Inotuzumab Ozogamicin Pre- and Post-Allogeneic Transplantation
The goal of this phase II clinical study is to learn about the safety of inotuzumab ozogamicin when given with fludarabine, with or without bendamustine, melphalan, and rituximab before and after a stem cell transplant. Researchers also want to learn if inotuzumab ozogamicin when given after a stem cell transplant can help control leukemia and lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab attaches to CD22-positive cancer cells in a targeted way and delivers ozogamicin to kill them. Giving chemotherapy before a bone marrow or peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. Sometimes the transplanted cells from a donor attack the body's normal cells (called graft-versus-host disease). Giving tacrolimus and filgrastim before or after the transplant may stop this from happening. Fludarabine, bendamustine, melphalan, and rituximab are commonly given before stem cell transplants. Giving inotuzumab ozogamicin with chemotherapy may work better in treating patients with leukemia or lymphoma undergoing stem cell transplantation.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the safety of the addition of inotuzumab ozogamicin (IO) pre- and post-allogeneic transplantation in patients with CD22-positive hematological malignancies.
SECONDARY OBJECTIVES:
- Overall survival, progression-free survival and relapse rates. II. Treatment-related mortality. III. Cumulative incidence of acute and chronic graft-versus-host disease (GVHD).
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients with acute lymphoblastic leukemia (ALL) and aggressive lymphoma receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -2, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal.
GROUP II: Patients with indolent lymphoma receive inotuzumab ozogamicin IV over 1 hour on day -13, fludarabine IV over 1 hour and bendamustine IV over 30 minutes to 1 hour on days -5 to -3, and tacrolimus IV continuously beginning on day -2 then PO QD or BID for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients then receive rituximab IV over 4-6 hours on days 1 and 8, cyclophosphamide IC over 3 hours and mesna IV on days +3 to +4, and filgrastim-sndz SC once a day beginning 1 week after the transplant.
MAINTENANCE: Between 45 and 100 days after stem cell transplantation, all patients receive inotuzumab ozogamicin IV over 1 hour on days 1 and 2. Beginning 28 to 100 days after start of first cycle, patients receive inotuzumab ozogamicin IV over 1 hour on days 1 and 2 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
GROUP III: Recipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal.
- Conditions
- Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, Lymphocytic Neoplasm, Lymphoma
- Being tested
- Allogeneic Bone Marrow Transplantation, Bendamustine, Filgrastim-sndz, Fludarabine, Inotuzumab Ozogamicin
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Bone Marrow TransplantationProcedure or surgery
Also called Allo BMT, Allogeneic Blood and Marrow Transplantation, Allogeneic BMT
Given IV
BendamustineDrug
Also called SDX-105
Given IV
Filgrastim-sndzBiological
Also called Filgrastim Biosimilar Filgrastim-sndz, Zarxio
Given IV
FludarabineDrug
Also called Fluradosa
Given IV
Inotuzumab OzogamicinBiological
Also called Besponsa, CMC-544, Way 207294, WAY-207294
Given IV
MelphalanDrug
Also called Alanine Nitrogen Mustard, CB-3025, L-PAM, L-Phenylalanine Mustard
Given IV
Peripheral Blood Stem Cell TransplantationProcedure or surgery
Also called PBPC transplantation, PBSCT, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support
Given IV
RituximabBiological
Also called ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody
Given IV
TacrolimusDrug
Also called FK 506, Fujimycin, Hecoria, Prograf
Given IV and PO
| Study group | Role | What they receive |
|---|---|---|
| Group I (inotuzumab ozogamicin, chemotherapy, transplant) | Experimental | Recipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal. Receives: Procedure: Allogeneic Bone Marrow Transplantation; Biological: Filgrastim-sndz; Drug: Fludarabine; Biological: Inotuzumab Ozogamicin; Drug: Melphalan; Procedure: Peripheral Blood Stem Cell Transplantation; Biological: Rituximab; Drug: Tacrolimus |
| Group II (inotuzumab ozogamicin, chemotherapy, transplant) | Experimental | Recipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal. Receives: Procedure: Allogeneic Bone Marrow Transplantation; Drug: Bendamustine; Biological: Filgrastim-sndz; Drug: Fludarabine; Biological: Inotuzumab Ozogamicin; Procedure: Peripheral Blood Stem Cell Transplantation; Biological: Rituximab; Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants Who Experienced VOD (Veno-occlusive Disease) Within 45 Days Post Transplant.
VOD (veno-occlusive disease) is a severe liver injury caused by chemotherapy drugs and it is usually presents with abdominal pain and swelling, with evidence of portal hypertension and variable degrees of serum enzyme elevations and jaundice.
Measured: Up to 45 days post transplant
Secondary outcomes (2)
Number of Participants Experienced Treatment-related Mortality (TRM) at 1 Year Post Transplant.
Number of participants die from cause other than relapsed disease.
Measured: Up to 1 year post transplant.
Progression-free Survival (PFS)
Number of participants that are disease free and alive 3 years after study enrollment.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start28 Oct 2019
- Primary completion13 Oct 2025
- Study completion13 Oct 2025
Why it stopped: \<75% participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Issa F Khouri, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856216
- Sponsor's protocol ID
- 2018-0860
- Other IDs
- NCI-2019-00531, 2018-0860
- Status last verified
- Mar 2026
- First submitted
- 21 Feb 2019
- Last updated
- 15 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.
PubMed 41671463
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Inotuzumab Ozogamicin Pre- and Post-Allogeneic Transplantation
- ClinicalTrials.gov ID
- NCT03856216
- Acronym / sponsor ID
- 2018-0860
- Conditions
- Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, Lymphocytic Neoplasm, Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: \<75% participation
- Enrolment
- 15 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 13 Oct 2025 (actual)
- Study completion
- 13 Oct 2025 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Posted 15 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this phase II clinical study is to learn about the safety of inotuzumab ozogamicin when given with fludarabine, with or without bendamustine, melphalan, and rituximab before and after a stem cell transplant. Researchers also want to learn if inotuzumab ozogamicin when given after a stem cell transplant can help control leukemia and lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab attaches to CD22-positive cancer cells in a targeted way and delivers ozogamicin to kill them. Giving chemotherapy before a bone marrow or peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. Sometimes the transplanted cells from a donor attack the body's normal cells (called graft-versus-host disease). Giving tacrolimus and filgrastim before or after the transplant may stop this from happening. Fludarabine, bendamustine, melphalan, and rituximab are commonly given before stem cell transplants. Giving inotuzumab ozogamicin with chemotherapy may work better in treating patients with leukemia or lymphoma undergoing stem cell transplantation.
Detailed description
PRIMARY OBJECTIVE:
- To assess the safety of the addition of inotuzumab ozogamicin (IO) pre- and post-allogeneic transplantation in patients with CD22-positive hematological malignancies.
SECONDARY OBJECTIVES:
- Overall survival, progression-free survival and relapse rates. II. Treatment-related mortality. III. Cumulative incidence of acute and chronic graft-versus-host disease (GVHD).
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients with acute lymphoblastic leukemia (ALL) and aggressive lymphoma receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -2, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal.
GROUP II: Patients with indolent lymphoma receive inotuzumab ozogamicin IV over 1 hour on day -13, fludarabine IV over 1 hour and bendamustine IV over 30 minutes to 1 hour on days -5 to -3, and tacrolimus IV continuously beginning on day -2 then PO QD or BID for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients then receive rituximab IV over 4-6 hours on days 1 and 8, cyclophosphamide IC over 3 hours and mesna IV on days +3 to +4, and filgrastim-sndz SC once a day beginning 1 week after the transplant.
MAINTENANCE: Between 45 and 100 days after stem cell transplantation, all patients receive inotuzumab ozogamicin IV over 1 hour on days 1 and 2. Beginning 28 to 100 days after start of first cycle, patients receive inotuzumab ozogamicin IV over 1 hour on days 1 and 2 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
GROUP III: Recipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (inotuzumab ozogamicin, chemotherapy, transplant) | Experimental | Procedure: Allogeneic Bone Marrow Transplantation, Biological: Filgrastim-sndz, Drug: Fludarabine, Biological: Inotuzumab Ozogamicin, Drug: Melphalan, Procedure: Peripheral Blood Stem Cell Transplantation, Biological: Rituximab, Drug: TacrolimusRecipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal. |
| Group II (inotuzumab ozogamicin, chemotherapy, transplant) | Experimental | Procedure: Allogeneic Bone Marrow Transplantation, Drug: Bendamustine, Biological: Filgrastim-sndz, Drug: Fludarabine, Biological: Inotuzumab Ozogamicin, Procedure: Peripheral Blood Stem Cell Transplantation, Biological: Rituximab, Drug: TacrolimusRecipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Participants age 12 to 75.
- English and non-English speaking participants are eligible.
- CD22+ lymphoid malignancies including B-ALL
- Eligible to receive a reduced-intensity alloSCT
- Indolent lymphoma participants who failed conventional treatment; or,
Key exclusion criteria (12 listed)
- Human immunodeficiency virus (HIV) positive.
- Prior autologous transplant less than 1 year prior to consent.
- Active and uncontrolled disease/infection.
- Unable or unwilling to sign consent.
- Current active hepatic or biliary disease (with exception of Gilbert's syndrome).
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 |
|---|---|---|
| Allogeneic Bone Marrow TransplantationAlso: Allo BMT, Allogeneic Blood and Marrow Transplantation, Allogeneic BMTGiven IV | Procedure or surgery | Group I (inotuzumab ozogamicin, chemotherapy, transplant), Group II (inotuzumab ozogamicin, chemotherapy, transplant) |
| BendamustineAlso: SDX-105Given IV | Drug | Group II (inotuzumab ozogamicin, chemotherapy, transplant) |
| Filgrastim-sndzAlso: Filgrastim Biosimilar Filgrastim-sndz, ZarxioGiven IV | Biological | Group I (inotuzumab ozogamicin, chemotherapy, transplant), Group II (inotuzumab ozogamicin, chemotherapy, transplant) |
| FludarabineAlso: FluradosaGiven IV | Drug | Group I (inotuzumab ozogamicin, chemotherapy, transplant), Group II (inotuzumab ozogamicin, chemotherapy, transplant) |
| Inotuzumab OzogamicinAlso: Besponsa, CMC-544, Way 207294, WAY-207294Given IV | Biological | Group I (inotuzumab ozogamicin, chemotherapy, transplant), Group II (inotuzumab ozogamicin, chemotherapy, transplant) |
| MelphalanAlso: Alanine Nitrogen Mustard, CB-3025, L-PAM, L-Phenylalanine MustardGiven IV | Drug | Group I (inotuzumab ozogamicin, chemotherapy, transplant) |
| Peripheral Blood Stem Cell TransplantationAlso: PBPC transplantation, PBSCT, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell SupportGiven IV | Procedure or surgery | Group I (inotuzumab ozogamicin, chemotherapy, transplant), Group II (inotuzumab ozogamicin, chemotherapy, transplant) |
| RituximabAlso: ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 AntibodyGiven IV | Biological | Group I (inotuzumab ozogamicin, chemotherapy, transplant), Group II (inotuzumab ozogamicin, chemotherapy, transplant) |
| TacrolimusAlso: FK 506, Fujimycin, Hecoria, PrografGiven IV and PO | Drug | Group I (inotuzumab ozogamicin, chemotherapy, transplant), Group II (inotuzumab ozogamicin, chemotherapy, transplant) |
Primary outcome
The Number of Participants Who Experienced VOD (Veno-occlusive Disease) Within 45 Days Post Transplant.
Time frame: Up to 45 days post transplant
VOD (veno-occlusive disease) is a severe liver injury caused by chemotherapy drugs and it is usually presents with abdominal pain and swelling, with evidence of portal hypertension and variable degrees of serum enzyme elevations and jaundice.
2 secondary outcomes
Number of Participants Experienced Treatment-related Mortality (TRM) at 1 Year Post Transplant.
Time frame: Up to 1 year post transplant.
Progression-free Survival (PFS)
Time frame: Up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41671463Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Issa F Khouri principal investigator
M.D. Anderson Cancer Center
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 Allogeneic Bone Marrow Transplantation, Bendamustine and Filgrastim-sndz in people with Acute Lymphoblastic Leukemia and B Acute Lymphoblastic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
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 16 inclusion and 12 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: stopped early, as of the sponsor's last update on 15 Apr 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 15 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants Who Experienced VOD (Veno-occlusive Disease) Within 45 Days Post Transplant. (time frame: Up to 45 days post transplant). 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 NCT03856216, which also lists 1 linked publication.
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 Apr 2026.