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.
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

June 28, 2011
November 14, 2011
August 2011
August 2014   (final data collection date for primary outcome measure)
Acute graft versus host disease rate,severity and response to treatment [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01385072 on ClinicalTrials.gov Archive Site
relapse rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pilot Study of Hematopoietic Stem Cell Transplantation From Two Matched Sibling Donors in Treating Patients With Poor Prognosis Acute Leukemia and Advanced Lymphoproliferative Malignancies
Pilot Study of Hematopoietic Stem Cell Transplantation From Two Matched Sibling Donors in Treating Patients With Poor Prognosis Acute Leukemia and Advanced Lymphoproliferative Malignancies

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Relapsed and Refractory Acute Leukemia
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.

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.

Intervention: Biological: Double matched sibling transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
April 2015
August 2014   (final data collection date for primary outcome measure)

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 -
Both
18 Years and older
No
Contact: Moshe Yeshurun, MD 972-9378127 moshey@clalit.org.il
Contact: Ron Ram, MD 972-9378116 RonRa@clalit.org.il
Israel
 
NCT01385072
6188
No
Rabin Medical Center
Rabin Medical Center
Not Provided
Principal Investigator: Moshe Yeshurun, MD Davidoff cancer center, Beilinson hospital, Rabin Medical Center
Rabin Medical Center
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP