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

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 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:

MedlinePlus related topics: Leukemia

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

relapse rate [ Time Frame: 12 months ]


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.

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 (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18 years or older
Patients with refractory or relapsed acute leukemia unable to receive myeloablative conditioning.
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.
Patients with 2 matched siblings and donor age > 18 years old.
Patients with advanced multiple myeloma with life expectancy of less than 6 months with standard therapy or transplantation.
Patients with advanced lymphoma with life expectancy of less than 6 months with standard therapy or transplantation.

Exclusion Criteria:

Patient age < 18 years.
Donor age < 18 years.
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


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

Keywords provided by Rabin Medical Center:


acute leukemia relapse induction failure allogeneic transplantation graft versus leukemia effect

Additional relevant MeSH terms:


Leukemia Acute Disease Neoplasms by Histologic Type	Neoplasms Disease Attributes Pathologic Processes

ClinicalTrials.gov processed this record on June 22, 2017