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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Cumulative incidence of NRM.
Cumulative incidence of acute grade II-IV GVHD.
Cumulative incidence of acute grade III-IV GVHD
+5 moreTrial 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
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
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,905 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,820 Total Patients Enrolled
1 Trials studying Blood Cancers
130 Patients Enrolled for Blood Cancers
Richard Ambinder, MDPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2 Previous Clinical Trials
32 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any untreated infections.I have not had a bone marrow transplant from another person.My leukemia has spread outside the bone marrow but is now in remission.My donor's HLA type does not match mine exactly.I am between 6 months and 75 years old.I don't have a matching bone marrow donor.My acute leukemia is in first remission with less than 5% bone marrow blasts.My acute leukemia has returned or is not responding to treatment, but I am currently in remission.My aggressive non-Hodgkin lymphoma is in complete remission.My leukemia affects less than 20% of my bone marrow.My last bone marrow transplant was over 3 months ago.I don't have a closely related donor who matches half of my genetic markers.I've had specific treatments or a bone marrow transplant to reduce graft rejection risk.
Research Study Groups:
This trial has the following groups:- Group 1: REGIMEN B
- Group 2: REGIMEN B2
- Group 3: REGIMEN C
- Group 4: REGIMEN B3: HIV patients with CCRd32 homozygous donors
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are octogenarians still able to enroll in this research study?
"As specified in the age range that is eligible for this study, the minimum age is 6 months and the maximum age is 75."
Answered by AI
What are the primary diseases that REGIMEN B2 is used to target?
"REGIMEN B2 is most frequently used in the treatment of organ transplantation patients. It has also shown efficacy in treating other conditions like dermatitis, atopic, multiple sclerosis, leukemia, myelocytic, acute."
Answered by AI
What are the ideal characteristics for participants in this medical study?
"This trial is only for cancer patients that fit the following age, treatment, and health criteria: being between 6 months and 75 years old, having a cancer that is in its second or later remission, having a cytogenetic make-up that is poor-risk, and being ineligible for a bone marrow transplant."
Answered by AI
Are there any similar studies to REGIMEN B2?
"As of now, 1124 clinical trials are running for REGIMEN B2 with 197 of those being in the third stage. Even though the majority of these REGIMEN B2 trials are based in Philadelphia, Pennsylvania, there are 30146 locations worldwide conducting these studies."
Answered by AI
Is this study still recruiting patients who wish to enroll?
"The most recent information from clinicaltrials.gov suggests that this trial is still seeking volunteers. The original posting was on September 1st, 2010, with the last edit on February 14th, 2022."
Answered by AI
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