Recurrent B Acute Lymphoblastic LeukemiaPhase 1NCT03991884
Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia
A Phase 1 study testing Etoposide, Doxorubicin and Vincristine in people with Recurrent B Acute Lymphoblastic Leukemia and Recurrent B Lymphoblastic Lymphoma, run by University of Washington at 1 site in United States.
Trial summary
This phase I trial studies the best dose of inotuzumab ozogamicin in combination with chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has come back (recurrent) or that does not respond to treatment (refractory). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent B Acute Lymphoblastic Leukemia, Recurrent B Lymphoblastic Lymphoma, Refractory B Acute Lymphoblastic Leukemia
- What is being tested?
- Etoposide, Doxorubicin and Vincristine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2019to 28 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a confirmed diagnosis of CD22-positive, Philadelphia chromosome (Ph)-positive or Ph-negative B-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. CD22 expression will be determined by multiparameter flow cytometry (MFC) or immunohistochemistry.
- Relapsed or refractory disease, as defined by any of the following:
- Unable to achieve complete response (CR) despite >= 4 weeks of initial course of systemic therapy.
- Recurrence of disease at any point after CR was achieved.
- (Note: patients with Ph-positive disease must have received >= 1 second- or third-generation ABL kinase inhibitor as part of their prior treatment to be eligible.)
- Detectable disease, as defined by any of the following:
Show all 18Show fewer
- Presence of >= 5% abnormal blasts in the bone marrow or peripheral blood by morphology or MFC.
- Patients with isolated extramedullary disease will be permitted if there is >= 1 site of disease that measures >= 1.5 cm in longest diameter on cross-sectional imaging.
- Absolute neutrophil count (ANC) >= 1,000/uL.
- Hemoglobin >= 8 g/dL.
- Platelets >= 50,000/uL.
- Note: Transfusions and growth factor support will be permitted within 3 days of initiation of study treatment to reach these thresholds. As patients with relapsed/refractory ALL frequently have cytopenias due to marrow infiltration by the disease, no hematologic parameters will be required for enrollment if cytopenias can be attributed to disease.
- Total serum bilirubin =< 1.5 x upper limit of normal (ULN); (unless due to Gilbert syndrome or hemolysis; =< 2 x ULN for hepatic abnormalities considered disease-related).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN.
- Serum creatinine =< 1.5 x ULN or serum creatinine level associated with a measured or calculated creatinine clearance of >= 40 mL/min.
- Corrected QT (QTc) interval =< 500 msec; if assessed, left ventricular ejection fraction >= 40%.
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Must agree to the use of effective contraception while on study treatment, unless they are highly unlikely to conceive (defined as [1] surgically sterilized, or [2] women who are and men whose sexual partner[s] is/are postmenopausal [i.e., a woman who is > 50 years old or who has not had menses for >= 1 year], or [3] not heterosexually active for the duration of the study).
Who cannot join
- Patients with a circulating blast count of > 50,000/uL; systemic therapy with either hydroxyurea, vincristine, and/or corticosteroids will be permitted within 3 days of initiation of study treatment to reduce the blast count.
- Except for management of circulating blasts noted above, adequate duration from prior therapy must be achieved before initiation of study treatment, as defined below:
- No cytotoxic or targeted systemic therapy < 2 weeks or 5 half-lives (whichever is shorter).
- No blinatumomab < 2 weeks.
- No radiation therapy < 4 weeks.
- No monoclonal antibody therapy < 6 weeks (except for prior InO, as discussed below).
Show all 16Show fewer
- Patients previously treated with InO will be eligible, unless they meet ANY of the following criteria:
- > 6 individual doses (e.g., > 2 standard cycles) were administered.
- Any documented hepatic toxicity observed was grade 3 or higher.
- The most recent dose was administered < 3 months from the initiation of study treatment.
- For patients that have received prior allogeneic HCT, they must be >= 4 months from the date of stem cell infusion, with no prior history of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD), and off all treatment for graft-vs-host disease (GVHD) for >= 2 weeks. Patients with minimal active symptoms that can be controlled with topical therapies and/or the equivalent of prednisone =< 10 mg/day will be eligible.
- For patients that have received other forms of cellular immunotherapy (e.g., chimeric antigen receptor-modified [CAR] T cells), they must be >= 21 days from cell infusion, and any specific manifestations of cytokine release syndrome or neurologic toxicity attributable to the cellular therapy have completely resolved (i.e., < grade 1)
- Patients with a known history of chronic liver disease, including but not limited to cirrhosis, steatohepatitis, and chronic viral hepatitis. Patients with a history of GVHD of the liver will be permitted, provided they meet all of the other eligibility criteria.
- Patients with isolated testicular or central nervous system disease.
- Known hypersensitivity or intolerance to any of the agents under investigation.
- May not be pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: A Phase I Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin Plus Escalating Doses of Inotuzumab Ozogamicin (DA-EPOCH-InO) in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
This phase I trial studies the best dose of inotuzumab ozogamicin in combination with chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has come back (recurrent) or that does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin in combination with chemotherapy may kill more cancer cells than with chemotherapy alone in treating patients with recurrent or refractory B-cell acute lymphoblastic leukemia.
Read the detailed description
This is a dose-escalation study of inotuzumab ozogamicin.
Patients receive etoposide, doxorubicin, and vincristine intravenously (IV) via continuous infusion on days 1-4, prednisone orally (PO) or IV twice daily (BID) on days 1-5, and cyclophosphamide IV over 1 hour on day 5. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 8 and 15. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days then annually for up to 5 years.
- Conditions
- Recurrent B Acute Lymphoblastic Leukemia, Recurrent B Lymphoblastic Lymphoma, Refractory B Acute Lymphoblastic Leukemia, Refractory B Lymphoblastic Lymphoma
- Being tested
- Etoposide, Doxorubicin, Vincristine, Prednisone, Cyclophosphamide
- Medical subject headings
- Burkitt Lymphoma, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoposideDrug
Also called 33419-42-0, Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet
Given IV
DoxorubicinDrug
Also called 14-Hydroxydaunomycin, 23214-92-8, Adriablastin, Hydroxydaunomycin
Given IV
VincristineDrug
Also called 22-Oxovincaleukoblastine, LEUROCRISTINE, VCR, Vincrystine
Given IV
PrednisoneDrug
Also called 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin
Given PO or IV
CyclophosphamideDrug
Also called Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal
Given IV
Inotuzumab OzogamicinBiological
Also called 635715-01-4, Besponsa, CMC-544, Way 207294
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Dose -1 (0.3 mg/m^2) | Experimental | Patients receive etoposide, doxorubicin, and vincristine IV via continuous infusion on days 1-4, prednisone PO or IV BID on days 1-5, and cyclophosphamide IV over 1 hour on day 5. Patients also receive inotuzumab ozogamicin IV over 1 hour on day 8. Treatment repeats approximately every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Receives: Drug: Etoposide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Cyclophosphamide; Biological: Inotuzumab Ozogamicin |
| Dose 1 (0.3 mg/m^2) | Experimental | Dose 1 patients receive etoposide, doxorubicin, and vincristine IV via continuous infusion on days 1-4, prednisone PO or IV BID on days 1-5, and cyclophosphamide IV over 1 hour on day 5. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 8 and 15. Treatment repeats approximately every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Receives: Drug: Etoposide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Cyclophosphamide; Biological: Inotuzumab Ozogamicin |
| Dose 2 (0.6 mg/m^2, 0.3 mg/m^2) | Experimental | Dose 2 patients receive etoposide, doxorubicin, and vincristine IV via continuous infusion on days 1-4, prednisone PO or IV BID on days 1-5, and cyclophosphamide IV over 1 hour on day 5. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 8 and 15. Treatment repeats approximately every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Receives: Drug: Etoposide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Cyclophosphamide; Biological: Inotuzumab Ozogamicin |
| Dose 3 (0.6 mg/m^2, 0.3 mg/m^2) | Experimental | Dose 3 patients receive etoposide, doxorubicin, and vincristine IV via continuous infusion on days 1-4, prednisone PO or IV BID on days 1-5, and cyclophosphamide IV over 1 hour on day 5. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 8 and 15. Treatment repeats approximately every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Receives: Drug: Etoposide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Cyclophosphamide; Biological: Inotuzumab Ozogamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of inotuzumab ozogamicin (InO)
Will be defined as the highest dose of InO administered in which the incidence of dose limiting toxicities (DLTs) is < 33%, assuming at least 6 patients have been treated at this dose. DLTs assessed by:
- Non-hematologic toxicities >= grade 3 evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 (except for febrile neutropenia/infection, unless felt to be a direct consequence of treatment-related toxicity [e.g., intestinal infection following mucosal barrier breakdown]).
- Any instance of possible, probably, or definite SOS/VOD
- Inability to complete 1 full cycle due to treatment-related adverse events
- Any treatment delays > 3 weeks (i.e., to Day 50 of Cycle 1) for recovery of prolonged toxicity
Measured: Up to 5 years
Secondary outcomes (6)
Complete response (CR) rate
Rate of complete response (CR) by bone marrow morphology and/or imaging.
Measured: Up to 5 years
Rate of complete minimal residual disease (MRD) response
Assessed by multiparameter flow cytometry (MFC).
Measured: Up to 5 years
Progression-free survival
Measured: Up to 5 years
Relapse-free survival
Measured: Up to 5 years
Overall survival
Measured: Up to 5 years
Rate at which patients proceed to subsequent allogeneic hematopoietic cell transplantation (HCT)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start24 Sep 2019
- Primary completion20 Oct 2022
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent B Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Ryan Cassaday, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991884
- Sponsor's protocol ID
- RG1004854
- Other IDs
- NCI-2019-03811, 8786
- Status last verified
- Jun 2023
- First submitted
- 17 Jun 2019
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kopmar NE, Quach K, Gooley TA, Martino CH, Cherian S, Percival MM, Halpern AB, Ghiuzeli CM, Oehler VG, Abkowitz JL, Walter RB, Cassaday RD. Dose-Adjusted EPOCH Plus Inotuzumab Ozogamicin in Adults With Relapsed or Refractory B-Cell ALL: A Phase 1 Dose-Escalation Trial. JAMA Oncol. 2024 Jul 1;10(7):961-965. doi: 10.1001/jamaoncol.2024.0967.
PubMed 38722664
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin Plus Escalating Doses of Inotuzumab Ozogamicin (DA-EPOCH-InO) in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT03991884
- Acronym / sponsor ID
- RG1004854
- Conditions
- Recurrent B Acute Lymphoblastic Leukemia, Recurrent B Lymphoblastic Lymphoma, Refractory B Acute Lymphoblastic Leukemia, Refractory B Lymphoblastic Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 19 Jun 2019 (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.
This phase I trial studies the best dose of inotuzumab ozogamicin in combination with chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has come back (recurrent) or that does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin in combination with chemotherapy may kill more cancer cells than with chemotherapy alone in treating patients with recurrent or refractory B-cell acute lymphoblastic leukemia.
Detailed description
This is a dose-escalation study of inotuzumab ozogamicin.
Patients receive etoposide, doxorubicin, and vincristine intravenously (IV) via continuous infusion on days 1-4, prednisone orally (PO) or IV twice daily (BID) on days 1-5, and cyclophosphamide IV over 1 hour on day 5. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 8 and 15. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days then annually for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose -1 (0.3 mg/m^2) | Experimental | Drug: Etoposide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisone, Drug: Cyclophosphamide, Biological: Inotuzumab OzogamicinPatients receive etoposide, doxorubicin, and vincristine IV via continuous infusion on days 1-4, prednisone PO or IV BID on days 1-5, and cyclophosphamide IV over 1 hour on day 5. Patients also receive inotuzumab ozogamicin IV over 1 hour on day 8. Treatment repeats approximately every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. |
| Dose 1 (0.3 mg/m^2) | Experimental | Drug: Etoposide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisone, Drug: Cyclophosphamide, Biological: Inotuzumab OzogamicinDose 1 patients receive etoposide, doxorubicin, and vincristine IV via continuous infusion on days 1-4, prednisone PO or IV BID on days 1-5, and cyclophosphamide IV over 1 hour on day 5. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 8 and 15. Treatment repeats approximately every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. |
| Dose 2 (0.6 mg/m^2, 0.3 mg/m^2) | Experimental | Drug: Etoposide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisone, Drug: Cyclophosphamide, Biological: Inotuzumab OzogamicinDose 2 patients receive etoposide, doxorubicin, and vincristine IV via continuous infusion on days 1-4, prednisone PO or IV BID on days 1-5, and cyclophosphamide IV over 1 hour on day 5. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 8 and 15. Treatment repeats approximately every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. |
| Dose 3 (0.6 mg/m^2, 0.3 mg/m^2) | Experimental | Drug: Etoposide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisone, Drug: Cyclophosphamide, Biological: Inotuzumab OzogamicinDose 3 patients receive etoposide, doxorubicin, and vincristine IV via continuous infusion on days 1-4, prednisone PO or IV BID on days 1-5, and cyclophosphamide IV over 1 hour on day 5. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 8 and 15. Treatment repeats approximately every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients must have a confirmed diagnosis of CD22-positive, Philadelphia chromosome (Ph)-positive or Ph-negative B-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. CD22 expression will be determined by multiparameter flow cytometry (MFC) or immunohistochemistry.
- Relapsed or refractory disease, as defined by any of the following:
- Detectable disease, as defined by any of the following:
- Absolute neutrophil count (ANC) >= 1,000/uL.
- Hemoglobin >= 8 g/dL.
Key exclusion criteria (16 listed)
- Patients with a circulating blast count of > 50,000/uL; systemic therapy with either hydroxyurea, vincristine, and/or corticosteroids will be permitted within 3 days of initiation of study treatment to reduce the blast count.
- Except for management of circulating blasts noted above, adequate duration from prior therapy must be achieved before initiation of study treatment, as defined below:
- Patients previously treated with InO will be eligible, unless they meet ANY of the following criteria:
- For patients that have received prior allogeneic HCT, they must be >= 4 months from the date of stem cell infusion, with no prior history of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD), and off all treatment for graft-vs-host disease (GVHD) for >= 2 weeks. Patients with minimal active symptoms that can be controlled with topical therapies and/or the equivalent of prednisone =< 10 mg/day will be eligible.
- For patients that have received other forms of cellular immunotherapy (e.g., chimeric antigen receptor-modified [CAR] T cells), they must be >= 21 days from cell infusion, and any specific manifestations of cytokine release syndrome or neurologic toxicity attributable to the cellular therapy have completely resolved (i.e., < grade 1)
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 |
|---|---|---|
| EtoposideAlso: 33419-42-0, Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, LastetGiven IV | Drug | Dose -1 (0.3 mg/m^2), Dose 1 (0.3 mg/m^2), Dose 2 (0.6 mg/m^2, 0.3 mg/m^2), Dose 3 (0.6 mg/m^2, 0.3 mg/m^2) |
| DoxorubicinAlso: 14-Hydroxydaunomycin, 23214-92-8, Adriablastin, HydroxydaunomycinGiven IV | Drug | Dose -1 (0.3 mg/m^2), Dose 1 (0.3 mg/m^2), Dose 2 (0.6 mg/m^2, 0.3 mg/m^2), Dose 3 (0.6 mg/m^2, 0.3 mg/m^2) |
| VincristineAlso: 22-Oxovincaleukoblastine, LEUROCRISTINE, VCR, VincrystineGiven IV | Drug | Dose -1 (0.3 mg/m^2), Dose 1 (0.3 mg/m^2), Dose 2 (0.6 mg/m^2, 0.3 mg/m^2), Dose 3 (0.6 mg/m^2, 0.3 mg/m^2) |
| PrednisoneAlso: 2-Dehydrocortisone, Adasone, Cortancyl, DacortinGiven PO or IV | Drug | Dose -1 (0.3 mg/m^2), Dose 1 (0.3 mg/m^2), Dose 2 (0.6 mg/m^2, 0.3 mg/m^2), Dose 3 (0.6 mg/m^2, 0.3 mg/m^2) |
| CyclophosphamideAlso: Carloxan, Ciclofosfamida, Ciclofosfamide, CicloxalGiven IV | Drug | Dose -1 (0.3 mg/m^2), Dose 1 (0.3 mg/m^2), Dose 2 (0.6 mg/m^2, 0.3 mg/m^2), Dose 3 (0.6 mg/m^2, 0.3 mg/m^2) |
| Inotuzumab OzogamicinAlso: 635715-01-4, Besponsa, CMC-544, Way 207294Given IV | Biological | Dose -1 (0.3 mg/m^2), Dose 1 (0.3 mg/m^2), Dose 2 (0.6 mg/m^2, 0.3 mg/m^2), Dose 3 (0.6 mg/m^2, 0.3 mg/m^2) |
Primary outcome
Maximum tolerated dose (MTD) of inotuzumab ozogamicin (InO)
Time frame: Up to 5 years
Will be defined as the highest dose of InO administered in which the incidence of dose limiting toxicities (DLTs) is < 33%, assuming at least 6 patients have been treated at this dose. DLTs assessed by: * Non-hematologic toxicities >= grade 3 evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 (except for febrile neutropenia/infection, unless felt to be a direct consequence of treatment-related toxicity [e.g., intestinal infection following mucosal barrier breakdown]). * Any instance of possible, probably, or definite SOS/VOD * Inability to complete 1 full cycle due to treatment-related adverse events * Any treatment delays > 3 weeks (i.e., to Day 50 of Cycle 1) for recovery of prolonged toxicity
6 secondary outcomes
Complete response (CR) rate
Time frame: Up to 5 years
Rate of complete minimal residual disease (MRD) response
Time frame: Up to 5 years
Progression-free survival
Time frame: Up to 5 years
Relapse-free survival
Time frame: Up to 5 years
Overall survival
Time frame: Up to 5 years
Rate at which patients proceed to subsequent allogeneic hematopoietic cell transplantation (HCT)
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Derived from this study: PubMed 38722664Kopmar NE, Quach K, Gooley TA, Martino CH, Cherian S, Percival MM, Halpern AB, Ghiuzeli CM, Oehler VG, Abkowitz JL, Walter RB, Cassaday RD. Dose-Adjusted EPOCH Plus Inotuzumab Ozogamicin in Adults With Relapsed or Refractory B-Cell ALL: A Phase 1 Dose-Escalation Trial. JAMA Oncol. 2024 Jul 1;10(7):961-965. doi: 10.1001/jamaoncol.2024.0967.
- Individual participant dataSharing planned: No
Related trials for Recurrent B Acute Lymphoblastic Leukemia
RecruitingPhase 1
Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)
B-All, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 2
Inotuzumab as Post-Trasplantation Therapy for Adult High-risk B-cell Precursor Acute Lymphoblastic Leukemia
Acute Lymphobkastic Leukemia, Adult
RecruitingPhase 2
Personalized NK Cell Therapy in CBT
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia
Active, not recruitingPhase 2
Study of Blinatumomab Administration in Chinese Pediatric Participants With Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)
B Precursor Acute Lymphoblastic Leukemia, Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia
RecruitingPhase 1
GN001 for Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and B-Cell Acute Lymphoblastic Leukemia
Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
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.
Ryan Cassaday principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Etoposide, Doxorubicin and Vincristine in people with Recurrent B Acute Lymphoblastic Leukemia and Recurrent B Lymphoblastic Lymphoma, run by University of Washington 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 18 inclusion and 16 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: finished, as of the sponsor's last update on 6 Jul 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum tolerated dose (MTD) of inotuzumab ozogamicin (InO) (time frame: Up to 5 years). 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 NCT03991884, 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 6 Jul 2023.