MITREL: A Phase II Study of Microtransplantation in Patients with Refractory or Relapsed Hematologic Malignancies

A Phase II Study of Microtransplantation in Patients with Refractory or Relapsed Hematologic Malignancies

Categories:

Leukemia / Lymphoma

Phase I/II

Diseases Treated:

Refractory or relapsed acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)

Eligibility Overview:

  • Patient should be is less than or equal to twenty-one years of age.
  • Patient has a diagnosis of AML or MDS that has relapsed or is refractory to chemotherapy or has relapsed after HSCT.
  • Patient has an available HPC-A donor.

Description

This study is enrolling patients who have leukemia that has either not gone into remission after treatment (refractory) or has come back after treatment (relapsed). This research study seeks to find out if low doses of chemotherapy followed by an infusion of donor stem cells collected from a family member will be a safe and effective treatment for leukemia. This type of therapy is called a microtransplant. Microtransplantation is a type of allogeneic transplant that uses a donor (usually a family member) who is not an exact match. In microtransplant, leukemia patients get lower doses of chemotherapy than in a traditional allogeneic transplant, which is then followed by an infusion of their donor’s peripheral blood stem cells. The doctors want to see if the donor cells will cause the body to mount an immunologic attack against the leukemia generating a response called the “graft-versus-leukemia” effect or “graft-versus-cancer” effect without causing the complications of graft-versus-host disease. The study doctors also want to see if microtransplantation will be a safe and effective treatment for children, adolescents, and young adults with relapsed or refractory leukemia.

Primary Objectives

  • To assess the safety and feasibility of standard chemotherapy plus GCSF- mobilized Hematopoietic Progenitor Cells, Apheresis (HPC-A) in pediatric patients with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
  • To estimate the response rates to standard chemotherapy plus GCSF-mobilized HPC-A in pediatric patients with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome. 

Secondary Objectives

  • To describe the event-free and overall survival of patients treated with standard chemotherapy plus GCSF-mobilized HPC-A.
  • To estimate the time to neutrophil and platelet recovery after treatment with standard chemotherapy plus GCSF-mobilized HPC-A.
  • To determine the cumulative incidence of acute and chronic graft-versus-host disease (GVHD).
  • To characterize donor chimerism and microchimerism.

Eligibility

  • Participant is less than or equal to twenty-one years of age (i.e. eligible until 22nd birthday).
  • Participant has a diagnosis of AML, or MDS, that has relapsed or is refractory to chemotherapy, or has relapsed after HSCT.
  • Participant has an available HPC-A donor.
  • Participant does not have an uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose. Infections controlled on concurrent anti-microbial agents are acceptable and anti-microbial prophylaxis per institutional guidelines is acceptable. 
  • Participant has fully recovered from the acute effects of all prior therapy.
  • Participant who received prior HSCT has no evidence of GVHD, is not receiving therapy, including steroids for GVHD and more than sixty (60) days have elapsed since HSCT.

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE  (1-866-278-5833).

Contact

Jeffrey Rubnitz, MD, PhD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334

Referring or consulting clinicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.