Intravenous Administration of RGI-2001 in Patient Undergoing Allogenic Hematopoietic Stem Cell Transplantation (AHSCT)

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Hematopoietic Stem Cell Transplant
NCT ID: NCT01379209 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-502

 

The clinical trial is a Phase 1/2a, open-label, multi-center, dose-escalation study to evaluate the safety, tolerability and pharmacokinetic profile of RGI-2001 in patients undergoing AHSCT, with radiation or non-radiation myeloablative preparative treatment. The study will be separated into two parts; a dose escalation phase to assess safety, followed by a large expansion phase to further evaluate the pharmacologic effects of either a Maximum Tolerated Dose, Maximum Feasible Dose or optimal pharmacologically active dose of RGI-2001. The initial dose escalation safety portion of the study (Part 1) will include higher risk patients and limit the unrelated donor transplants. After safety is established in part 1 of the study, the second portion of the study will expand the enrollment criteria and allow transplantation by either related or unrelated donors. This study will endeavor to identify the dose range at which RGI-2001 has an acceptable safety profile, at which biologic activity is observed, and to guide possible dose levels to utilize in later phase studies based on biological activity.

 

Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Yi-Bin Chen, MD, Massachusetts General Hospital

Site-responsible Investigators:

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: 1. Patients with hematological malignancies or myelodysplastic syndrome undergoing myeloablative therapy and a first allogeneic HSCT (AHSCT) 2. Male or female, age ≥ 18 years of age 3. Eastern Cooperative Oncology Group (ECOG) status of 0-2 or Karnofsky Performance Status (KPS) of > 60 4. Part 1 Dose Escalation AHSCT Procedure: 1. Patients with hematological malignancies or myelodysplastic syndrome undergoing a first AHSCT procedure and who are in their 2nd or subsequent remission 2. Type of allograft: Unrelated allogeneic hematopoietic stem cell transplant donor with no more than 1 HLA allele or antigen mismatch. 3. Source of allograft: Unmodified (non-manipulated) bone marrow. 4. Anti-graft versus host disease (GvHD) prophylaxis will include a calcineuron inhibitor [either tacrolimus (FK506) or cyclosporin A)], in combination with either methotrexate (MTX) or mycophenolate mofetil (MMF), all at doses as per the institutional protocols. 5. Part 2 Expansion AHSCT Procedure: 1. Patients with hematological malignancies or myelodysplastic syndrome undergoing a first AHSCT procedure and who are in their 1st (CR1) or subsequent complete remission 2. Type of allograft: Related or unrelated allogeneic hematopoietic stem cell transplant donors with no more than 1 HLA allele or antigen mismatch. 3. Source of allograft: Unmodified (non-manipulated), bone marrow or mobilized peripheral blood stem cell transplant (PBSCT) using G-CSF as the mobilizing agent. 4. Anti-graft versus host disease (GvHD) prophylaxis will include a calcineuron inhibitor [either tacrolimus (FK506) or cyclosporin A)], in combination with either methotrexate (MTX) or mycophenolate mofetil (MMF), all at doses as per the institutional protocols. Exclusion Criteria: 1. Female patients who are pregnant or lactating 2. Patients about to undergo mini allogeneic transplant (also known as reduced intensity transplant, non-ablative or non-myeloablative transplant, or adoptive immunotherapy) 3. Radiation, chemotherapy, immunotherapy in the previous 3 weeks, unrelated to the AHSCT procedure 4. Patient who is about to undergo cord blood transplantation 5. Procedures that are intended to deplete regulatory T-cells from donor transplant materials 6. Known or suspected HIV infection 7. Active hepatitis A, B, or C infection in recipient or donor 8. Prior treatment with anti-thymocyte globulin, anti-CD20, or anti-CD3 antibodies 9. Cardiac pacemaker or automatic implantable cardioverter-defibrillator 10. Prior autologous or allogeneic hematopoietic stem cell transplantation 11. Any other prior organ transplant
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