Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...

Registration Number
NCT05470491
Lead Sponsor
National Cancer Institute (NCI)
Brief Summary

Background:

People living with HIV(PLWH) are at a higher risk for cancers that may be curable with a bone marrow transplant. HIV infection itself is no longer a reason to not get a transplant, for patients who otherwise have a standard reason to need transplant.

Objective:
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Detailed Description

Background:

* Human Immunodeficiency Virus (HIV) infection should not be considered a barrier to hematopoietic cell transplantation (HCT) in patients who otherwise have a standard indication for HCT.

* The main historical barriers include the risk of opportunistic infections, drug interactions, and lack of donor availability.
...

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
265
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
2/Recipient Arm 2GVHD prophylaxisRIC+alloHCT+GVHD prophylaxis per RP2D
1/Recipient Arm 1allo HCTRIC+alloHCT+GVHD prophylaxis per dose levels 1, 2, and
1/Recipient Arm 1PlerixaforRIC+alloHCT+GVHD prophylaxis per dose levels 1, 2, and
2/Recipient Arm 2RICRIC+alloHCT+GVHD prophylaxis per RP2D
1/Recipient Arm 1MaravirocRIC+alloHCT+GVHD prophylaxis per dose levels 1, 2, and
1/Recipient Arm 1RICRIC+alloHCT+GVHD prophylaxis per dose levels 1, 2, and
1/Recipient Arm 1GVHD prophylaxisRIC+alloHCT+GVHD prophylaxis per dose levels 1, 2, and
2/Recipient Arm 2allo HCTRIC+alloHCT+GVHD prophylaxis per RP2D
2/Recipient Arm 2MaravirocRIC+alloHCT+GVHD prophylaxis per RP2D
2/Recipient Arm 2PlerixaforRIC+alloHCT+GVHD prophylaxis per RP2D
Primary Outcome Measures
NameTimeMethod
Determine a safe and recommended phase II dose level regimenday +100 post HCT

Number and type of toxicities noted for participants who are evaluable

In phase II, avoidance rate of grade III-IV acute GVHD at day +100day +100 post HCT

Proportion of evaluable recipients who experience grade III-IV acute GVHD at day +100 will be reported along with 80% and 95% two-sided confidence interval

Secondary Outcome Measures
NameTimeMethod
Cumulative incidence of relapse1, 3, and 5 years post HCT

Cumulative incidence rates will be estimated based on disease-risk index.

Cumulative incidence of hematopoietic recoveryday +100

cumulative incidence of hematopoietic recovery will be based on platelet recover at day +100

Cumulative incidence of primary and secondary graft failureday +100 and 1 year post HCT

Cumulative incidence of primary and secondary graft failure based on chimerism at day +100 and 1 year post transplant

Cumulative incidence of chronic GVHD1 and 2 years post HCT

Evaluation by severity of mild, moderate, and severe

Progression Free Survival (PFS)1, 3, and 5 years post HCT

Time from transplant to disease progression and will be determined using the Kaplan-Meier method

Cumulative incidence of transplant-related mortality (TRM)day +100, 1 year, and 2 years post HCT

cumulative incidence of transplant related mortality will be estimated

Cumulative incidence of acute GVHDDay +180 and 1 year post HCT

Evaluation by all grades, grade II-IV, and grade III-IV

Overall Survival1, 2, 3, 4, and 5 years post HCT

Time from transplant to death of any cause and will be determined using the Kaplan-Meier method

GVHD-free, relapse free survival (GRFS)1, 3, and 5 years post HCT

Time from transplant to death from any cause of other event and will be determined using the Kaplan-Meier method

Trial Locations

Locations (1)

National Institutes of Health Clinical Center

🇺🇸

Bethesda, Maryland, United States

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