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Bone Marrow Transplant for Blood Cancer

Phase 1 & 2

Recruiting

Led By Richard Ambinder, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient age 0.5-75 years

Absence of a suitable related or unrelated bone marrow donor who is molecularly matched at HLA-A, B, Cw, DRB1, and DQB1

Must not have

No uncontrolled bacterial, viral, or fungal infection

No previous allogeneic BMT (syngeneic BMT permissible)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to do bone marrow transplants using donors that are not related and don't have matching HLA types. The goal is to find a transplant regimen that has low rates of severe acute GVHD and NRM.

Who is the study for?

This trial is for people aged 0.5-75 with certain blood cancers or tumors who've had at least two prior treatments, or specific poor-risk features. They must have acceptable organ function and performance status, no suitable HLA-matched donor, and not be pregnant or breastfeeding. HIV-positive individuals may be considered on a case-by-case basis.

What is being tested?

The study tests a bone marrow transplant (BMT) from partially matched donors using nonmyeloablative conditioning to treat hematologic malignancies. It explores postgrafting immunosuppression regimens incorporating high-dose Cytoxan and sirolimus to manage graft-versus-host disease (GVHD) and non-relapse mortality.

What are the potential side effects?

Possible side effects include reactions to the transplant like GVHD where the donor cells attack the body, infections due to immune suppression, organ inflammation from medications like sirolimus and tacrolimus, as well as potential complications from chemotherapy drugs used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 6 months and 75 years old.

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I don't have a matching bone marrow donor.

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I don't have a closely related donor who matches half of my genetic markers.

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My acute leukemia has returned or is not responding to treatment, but I am currently in remission.

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My acute leukemia is in first remission with less than 5% bone marrow blasts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any untreated infections.

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I have not had a bone marrow transplant from another person.

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My donor's HLA type does not match mine exactly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

6-month probability of survival as assessed by absence of grade III-IV GVHD or evidence of graft failure.

Transplant regimen as determined by rates of severe acute graft-versus-host-disease (GVHD)

Transplant regimen as determined by rates of transplant-related nonrelapse mortality (NRM)

Secondary study objectives

Cumulative incidence of NRM.

Cumulative incidence of acute grade II-IV GVHD.

Cumulative incidence of acute grade III-IV GVHD

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Active Control

Group I: REGIMEN BActive Control6 Interventions

Pre-BMT : * Day -6 through -2: Fludarabine 30 mg/m2/day (adjusted for renal function; maximum cumulative dose, 150 mg/m2) administered IV * Day -6 and -5: Cytoxan 14.5 mg/kg/day administered IV * Day -1: 400 cGy total body irradiation (TBI) administered in a single fraction Day 0: Allogeneic blood or marrow transplantation (BMT) Post-Transplantation Immunosuppression Consisting of: * Day 3 and 4: High-dose Cytoxan 50mg/kg/day (adjusted according to IBW) administered IV * Day 5: Sirolimus loading dose 6 mg PO once * Day 5 thru Day 35: Mycophenolate Mofetil (MMF) 15 mg/kg PO TID (maximum daily dose 3 g/day) * Day 6 thru Day 180: Sirolimus maintenance dose 2 mg PO QD with dose adjustments to maintain trough of 3 - 12 ng/mL

Group II: REGIMEN B2Active Control6 Interventions

Pre-PBSCT: * Day -6 through -2: Fludarabine 30 mg/m2/day (adjusted for renal function; maximum cumulative dose, 150 mg/m2) administered IV * Day -6 and -5: Cytoxan 14.5 mg/kg/day administered IV * Day -1: 400 cGy TBI administered in a single fraction Day 0: Peripheral Blood Stem Cell Transplant (PBSCT) Post-Transplantation Immunosuppression Consisting of: * Day 3 and 4: High-dose Cytoxan 50mg/kg/day (adjusted according to IBW) administered IV * Day 5: Sirolimus loading dose 6 mg PO once * Day 5 thru Day 35: MMF 15 mg/kg PO TID (maximum daily dose 3 g/day) * Day 6 thru Day 180: Sirolimus maintenance dose 2 mg PO QD with dose adjustments to maintain trough of 3 - 12 ng/mL

Group III: REGIMEN CActive Control6 Interventions

Pre-BMT: * Day -6 through -2: Fludarabine 30 mg/m2/day (adjusted for renal function; maximum cumulative dose, 150 mg/m2) administered IV * Day -6 and -5: Cytoxan 14.5 mg/kg/day administered IV * Day -1: 400 cGy TBI administered in a single fraction Day 0: BMT Post-Transplantation Immunosuppression Consisting of: * Day 3 and 4: High-dose Cytoxan 50mg/kg/day (adjusted according to IBW) administered IV * Day 5 thru Day 35: MMF 15 mg/kg PO TID (maximum daily dose 3 g/day) * Day 5 thru Day 180: Tacrolimus 1 mg administered IV QD

Group IV: REGIMEN B3: HIV patients with CCRd32 homozygous donorsActive Control6 Interventions

0 / 8Eligibility criteria met