Pilot Study of Hematopoietic Stem Cell Transplantation From Two Matched Sibling Donors in Treating Patients With Poor Prognosis Acute Leukemia and Advanced Lymphoproliferative Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01385072
First received: June 28, 2011
Last updated: November 14, 2011
Last verified: June 2011
  Purpose

Patients with active acute leukemia have dismal prognoses even with allogeneic transplantation.Thus,new measures to enhance graft versus leukemia effect and reduce relapse rates are needed.

Relapse risk after double umbilical cord transplantations have been shown to be significantly lower compared to matched sibling and matched unrelated donor transplantations due to better graft versus leukemia effect.

The investigators hypothesize, that concomitant transplantation from 2 matched siblings may improve GVL effect and reduce relapse rate in patients with high risk acute leukemias and other high risk hematological malignancies.


Condition Intervention Phase
Relapsed and Refractory Acute Leukemia
Biological: Double matched sibling transplantation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Hematopoietic Stem Cell Transplantation From Two Matched Sibling Donors in Treating Patients With Poor Prognosis Acute Leukemia and Advanced Lymphoproliferative Malignancies

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Acute graft versus host disease rate,severity and response to treatment [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • relapse rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: August 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Double matched sibling transplantation

Patients with poor risk active acute leukemia and who have 2 matched sibling donors can be included. Patients' conditioning may be myeloablative or non-myeloablative. Both matched donors will be mobilized with G-CSF and their peripheral blood stem cells will be collected on day 0.Equal numbers of CD34+ cells from both donors will be transfused to the patient.

Patients will be followed for engraftment kinetics, chimerism, GVHD rate, severity and response to treatment, relapse rates, DFS and OS.

Biological: Double matched sibling transplantation

Patients with poor risk active acute leukemia and who have 2 matched sibling donors can be included. Patients' conditioning may be myeloablative or non-myeloablative. Both matched donors will be mobilized with G-CSF and their peripheral blood stem cells will be collected on day 0.Equal numbers of CD34+ cells from both donors will be transfused to the patient.

Patients will be followed for engraftment kinetics, chimerism, GVHD rate, severity and response to treatment, relapse rates, DFS and OS.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years or older
  2. Patients with refractory or relapsed acute leukemia unable to receive myeloablative conditioning.
  3. Patients with refractory or relapsed acute leukemia able to receive myeloablative conditioning but with the following factors:

    AML- 2 or more of the following: duration of CR1 < 6 months, poor cytogenetics, circulating blasts, karnofsky < 90.

    ALL- age > 40 or second and additional relapse, or 2 or more of the following: BM blasts > 25%, age 18-39,first refractory relapse, donor CMV positive.

  4. Patients with 2 matched siblings and donor age > 18 years old.
  5. Patients with advanced multiple myeloma with life expectancy of less than 6 months with standard therapy or transplantation.
  6. Patients with advanced lymphoma with life expectancy of less than 6 months with standard therapy or transplantation.

Exclusion Criteria:

  1. Patient age < 18 years.
  2. Donor age < 18 years.
  3. Patients in remission or not fulfilling above disease criteria -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385072

Contacts
Contact: Moshe Yeshurun, MD 972-9378127 moshey@clalit.org.il
Contact: Ron Ram, MD 972-9378116 RonRa@clalit.org.il

Locations
Israel
Davidoff Cancer Center, Beilin hospital, Rabin medical center Recruiting
Petach Tikva, Israel
Contact: Moshe Yeshurun, MD    972-3-9378127    moshey@clalit.org.il   
Contact: Ron Ram, MD    972-3-9378116    RonRa@clalit.org.il   
Principal Investigator: Moshe Yeshurun, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Moshe Yeshurun, MD Davidoff cancer center, Beilinson hospital, Rabin Medical Center
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01385072     History of Changes
Other Study ID Numbers: 6188
Study First Received: June 28, 2011
Last Updated: November 14, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Rabin Medical Center:
acute leukemia
relapse
induction failure
allogeneic transplantation
graft versus leukemia effect

Additional relevant MeSH terms:
Acute Disease
Leukemia
Disease Attributes
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014