A Phase 2 interventional study of Allogeneic Bone Marrow Transplantation and Bendamustine in Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia and Lymphocytic Neoplasm, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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.
PRIMARY OBJECTIVE:
I. 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:
I. 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.
2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.
This study's enrollment of 15 is below the median of 40 across 1,653 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with:
Adequate organ function at time of study entry
Exclusion Criteria:
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.
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.
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
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.
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
Given IV
Also known as: Allo BMT, Allogeneic Blood and Marrow Transplantation, Allogeneic BMT
Given IV
Also known as: SDX-105
Given IV
Also known as: Filgrastim Biosimilar Filgrastim-sndz, Zarxio
Given IV
Also known as: Fluradosa
Given IV
Also known as: Besponsa, CMC-544, Way 207294, WAY-207294
Given IV
Also known as: Alanine Nitrogen Mustard, CB-3025, L-PAM, L-Phenylalanine Mustard, L-Sarcolysin, L-Sarcolysin Phenylalanine mustard, L-Sarcolysine, Melphalanum, Phenylalanine Mustard, Phenylalanine Nitrogen Mustard, Sarcoclorin, Sarkolysin, WR-19813
Given IV
Also known as: PBPC transplantation, PBSCT, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell Transplant, Peripheral Stem Cell Transplantation
Given IV
Also known as: ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8, PF-05280586, Rituxan, Rituximab ABBS, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar IBI301, Rituximab Biosimilar JHL1101, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, rituximab biosimilar TQB2303, rituximab-abbs, RTXM83, Truxima
Given IV and PO
Also known as: FK 506, Fujimycin, Hecoria, Prograf, Protopic
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.
Time frame: Up to 45 days post transplant
Number of Participants Experienced Treatment-related Mortality (TRM) at 1 Year Post Transplant.
Number of participants die from cause other than relapsed disease.
Time frame: Up to 1 year post transplant.
Progression-free Survival (PFS)
Number of participants that are disease free and alive 3 years after study enrollment.
Time frame: Up to 3 years
All participants were registered at MD Anderson Cancer Center.
| Milestone | Cohort 1: BFR (Bendamustine/Fludarabine/Rituximab) | Cohort 2: FM (Fludarabine/Melphalan) |
|---|---|---|
| Started | 4 | 11 |
| Completed | 4 | 11 |
| Not completed | 0 | 0 |
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.
| Participants | Cohort 1: BFR (Bendamustine/Fludarabine/Rituximab) | Cohort 2: FM (Fludarabine/Melphalan) |
|---|---|---|
| The Number of Participants Who Experienced VOD (Veno-occlusive Disease) Within 45 Days Post Transplant. | 0 | 1 |
Number of participants die from cause other than relapsed disease.
| Participants | Cohort 1: BFR (Bendamustine/Fludarabine/Rituximab) | Cohort 2: FM (Fludarabine/Melphalan) |
|---|---|---|
| Number of Participants Experienced Treatment-related Mortality (TRM) at 1 Year Post Transplant. | 0 | 2 |
Number of participants that are disease free and alive 3 years after study enrollment.
| Participants | Cohort 1: BFR (Bendamustine/Fludarabine/Rituximab) | Cohort 2: FM (Fludarabine/Melphalan) |
|---|---|---|
| Progression-free Survival (PFS) | 2 | 6 |
Collected over 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: BFR (Bendamustine/Fludarabine/Rituximab) | 1/4 (25%) | 1/4 (25%) | 3/4 (75%) |
| Cohort 2: FM (Fludarabine/Melphalan) | 4/11 (36.4%) | 5/11 (45.5%) | 10/11 (90.9%) |
| Event | Cohort 1: BFR (Bendamustine/Fludarabine/Rituximab) | Cohort 2: FM (Fludarabine/Melphalan) |
|---|---|---|
| DiarrheaGastrointestinal disorders | 0/4 | 3/11 |
| Wbc decreasedInvestigations | 1/4 | 0/11 |
| Platelet count decreasedInvestigations | 0/4 | 2/11 |
| BacterialInfections and infestations | 0/4 | 1/11 |
| EdemaGeneral disorders | 0/4 | 1/11 |
| FungalInfections and infestations | 0/4 | 1/11 |
| Neutrophil count decreasedInvestigations | 0/4 | 1/11 |
| Wbc decreasedInvestigations | 0/4 | 1/11 |
| Event | Cohort 1: BFR (Bendamustine/Fludarabine/Rituximab) | Cohort 2: FM (Fludarabine/Melphalan) |
|---|---|---|
| DiarrheaGastrointestinal disorders | 1/4 | 10/11 |
| Low granulocyteBlood and lymphatic system disorders | 2/4 | 10/11 |
| NauseaGastrointestinal disorders | 3/4 | 10/11 |
| ALT increasedInvestigations | 3/4 | 7/11 |
| AST increasedInvestigations | 3/4 | 5/11 |
| HeadacheNervous system disorders | 1/4 | 8/11 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/4 | 7/11 |
| BacterialInfections and infestations | 1/4 | 6/11 |
| RashSkin and subcutaneous tissue disorders | 2/4 | 6/11 |
| Oral mucositisGastrointestinal disorders | 0/4 | 6/11 |
| Age, Categorical(Participants) | Cohort 1: BFR (Bendamustine/Fludarabine/Rituximab) | Cohort 2: FM (Fludarabine/Melphalan) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 9 | 13 |
| >=65 years | 0 | 2 | 2 |
| Sex: Female, Male(Participants) | Cohort 1: BFR (Bendamustine/Fludarabine/Rituximab) | Cohort 2: FM (Fludarabine/Melphalan) | Total |
|---|---|---|---|
| Female | 0 | 6 | 6 |
| Male | 4 | 5 | 9 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1: BFR (Bendamustine/Fludarabine/Rituximab) | Cohort 2: FM (Fludarabine/Melphalan) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 4 | 4 |
| Not Hispanic or Latino | 4 | 7 | 11 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Cohort 1: BFR (Bendamustine/Fludarabine/Rituximab) | Cohort 2: FM (Fludarabine/Melphalan) | Total |
|---|---|---|---|
| United States | 4 | 11 | 15 |
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Precursor Cell Lymphoblastic Leukemia-Lymphoma→
M.D. Anderson Cancer Center