search
Back to results

Study of Low Intensity Conditioning and Immunotherapy for High-Risk Cancers of the Blood

Primary Purpose

Leukemia, Lymphoma, Low-Grade, Lymphoma, Non-Hodgkin's

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Reduced intensity conditioning
Prophylactic donor leukocyte infusions
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Leukemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patient Inclusion Criteria: One of the following hematological malignancies: Chronic myelogenous leukemia Accelerated phase Blast phase Acute myelogenous leukemia First or greater complete remission if high risk features: abnormalities of chromosomes with known poor prognosis 5 or 7. Relapsed or refractory patients with ≤ 30% blasts Aged 55 years or older in any disease state beyond first remission if blast percentage is < 30%. Acute lymphoblastic leukemia First complete remission if high risk features: t(4;11) Second complete remission if relapse occurs within the first 12 months of therapy Third or greater complete remission Relapsed or refractory patients with ≤ 30% blasts Aged 55 years or old in second in any disease state beyond first remission if blast percentage is < 30%. Myelodyplastic syndromes RAEB or RAEB-t patients, 55 years of age or older Any hematologic malignancy relapsed following autologous or matched related donor allogeneic stem cell transplant provided at least 90 days has elapsed from most recent transplant Non-Hodgkin's Lymphoma 55 years or older, who have failed anthracycline containing regimen and do not have any tumor larger than 5 cm in diameter. Patients with rapidly progressive disease are ineligible. Multiple myeloma patients, any age, who meet at least one of the following criteria: disease refractory to conventional chemotherapy such as VAD, pulse decadron, or alkylating agents, OR chromosomal abnormality by cytogenetics or FISH probe. Chronic lymphoblastic leukemia patients Any age Advanced disease (Rai stage 3 or 4) Relapsed following/refractory to alkylating agents or nucleoside analog therapy NOTE: Patients with bulky disease (lymphadenopathy > 5 cm) or progressive disease NOT eligible. Mantle cell lymphoma Any age Disease stage 3 or 4 Lymphadenopathy must not exceed 5 cm in any dimension Any eligible disease category, any age, if ineligible for myeloablative conditioning because of organ dysfunction or advanced age (55 years or older). Minimum organ function for patients entered on this protocol defined as: Cardiac: Ejection fraction at least 30%. Renal: Creatinine <1.5 times normal for age. Pulmonary: FEV1 and FVC >60%. Hepatic: Total bilirubin <2.0 and AST/ALT <3 X institutional normal for age. Performance (adults): Karnofsky score must be at least 60; for pts. under 16, Lansky score must be at least 60. Low grade lymphoma (small lymphocytic, follicular small cleaved cell, or follicular mixed small cleaved and large cell) must meet the following criteria: any age relapsed or refractory disease provided the disease is NOT rapidly progressive no lymphoma mass or lymph node exceeds 5 cm in greatest dimension Age: no age restriction Availability of a 6/6 HLA A, B, and DR identical relative who is willing and able to donate allogeneic stem cells No active infection Serum creatinine less than 1.5 times normal for age Serum bilirubin less than 1.5 times normal for age Not pregnant. Patient Exclusion Criteria: HIV positive patients not eligible Pregnant Donor Inclusion Criteria: 6/6 HLA match for HLA-A, B, and DR Age 3-70 years, good general health No contraindication to G-CSF stimulation No contraindication to leukapheresis of peripheral blood stem cells Good general health Donor Exclusion Criteria: HIV positive or history of HIV risk factors Presence of other diseases transmissible by blood that pose unacceptable risk to the study subject. Pregnant Medical or psychological conditions that would make the donor unlikely to tolerate G-CSF injections or leukapheresis

Sites / Locations

  • The University of Michigan

Outcomes

Primary Outcome Measures

To conduct a phase I-II trial of prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies

Secondary Outcome Measures

To evaluate both surrogate markers of GVHD (with a cytokine panel) and minimal residual disease and correlate these with clinical outcomes during the above trial

Full Information

First Posted
August 31, 2005
Last Updated
April 20, 2007
Sponsor
University of Michigan Rogel Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00143884
Brief Title
Study of Low Intensity Conditioning and Immunotherapy for High-Risk Cancers of the Blood
Official Title
Adjuvant Cellular Immunotherapy for High-Risk Hematologic Malignancy After Allogeneic Stem Cell Transplantation Using Low Intensity Conditioning
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Terminated
Study Start Date
March 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Michigan Rogel Cancer Center

4. Oversight

5. Study Description

Brief Summary
This research project will focus on whether it is safe and effective to rely on donor cells to prevent relapse of leukemia, lymphoma, or other blood cancer after bone marrow stem cell transplant.
Detailed Description
This research project will focus on whether it is safe and effective to rely on donor cells to prevent relapse of leukemia, lymphoma, or other blood cancer after bone marrow stem cell transplant (SCT). For many patients with these conditions, a bone marrow transplant can be the only chance for cure. The standard type of bone marrow transplant involves giving very high-doses of chemotherapy and radiation to kill all the cancer cells followed by an infusion of bone marrow stem cells from a relative who is a bone marrow match. After the transplant the patient takes anti-rejection drugs for many months to prevent the donor's immune cells from causing a severe reaction called Graft-versus-Host Disease (GVHD), which can even be fatal. However, for some patients with certain types of high-risk cancer even this intense treatment is not effective and the cancer relapses. Is has been known for many years that some of the bone marrow cells from the donor can kill cancer cells. Recently, it has been discovered that sometimes patients who relapse after a bone marrow SCT can be cured by giving an infusion of donor white blood cells (called a donor leukocyte infusion or DLI). By giving a DLI BEFORE a relapse happens, hopefully relapse can be prevented. The high doses of chemotherapy and radiation therapy given prior to a standard bone marrow stem cell transplant can make a patient very sick and also increase the chance of getting severe GVHD. In this research study we are going to rely mainly on the donor cells to kill the cancer cells, and patients will receive dosages of chemotherapy that are lower than the usual dosages. It is thought that this low intensity conditioning will make the transplant safer without risking more relapses, however it is not know whether low intensity conditioning is safer than standard conditioning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma, Low-Grade, Lymphoma, Non-Hodgkin's, Multiple Myeloma, Myelodysplastic Syndromes

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Reduced intensity conditioning
Intervention Type
Procedure
Intervention Name(s)
Prophylactic donor leukocyte infusions
Primary Outcome Measure Information:
Title
To conduct a phase I-II trial of prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies
Secondary Outcome Measure Information:
Title
To evaluate both surrogate markers of GVHD (with a cytokine panel) and minimal residual disease and correlate these with clinical outcomes during the above trial

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Patient Inclusion Criteria: One of the following hematological malignancies: Chronic myelogenous leukemia Accelerated phase Blast phase Acute myelogenous leukemia First or greater complete remission if high risk features: abnormalities of chromosomes with known poor prognosis 5 or 7. Relapsed or refractory patients with ≤ 30% blasts Aged 55 years or older in any disease state beyond first remission if blast percentage is < 30%. Acute lymphoblastic leukemia First complete remission if high risk features: t(4;11) Second complete remission if relapse occurs within the first 12 months of therapy Third or greater complete remission Relapsed or refractory patients with ≤ 30% blasts Aged 55 years or old in second in any disease state beyond first remission if blast percentage is < 30%. Myelodyplastic syndromes RAEB or RAEB-t patients, 55 years of age or older Any hematologic malignancy relapsed following autologous or matched related donor allogeneic stem cell transplant provided at least 90 days has elapsed from most recent transplant Non-Hodgkin's Lymphoma 55 years or older, who have failed anthracycline containing regimen and do not have any tumor larger than 5 cm in diameter. Patients with rapidly progressive disease are ineligible. Multiple myeloma patients, any age, who meet at least one of the following criteria: disease refractory to conventional chemotherapy such as VAD, pulse decadron, or alkylating agents, OR chromosomal abnormality by cytogenetics or FISH probe. Chronic lymphoblastic leukemia patients Any age Advanced disease (Rai stage 3 or 4) Relapsed following/refractory to alkylating agents or nucleoside analog therapy NOTE: Patients with bulky disease (lymphadenopathy > 5 cm) or progressive disease NOT eligible. Mantle cell lymphoma Any age Disease stage 3 or 4 Lymphadenopathy must not exceed 5 cm in any dimension Any eligible disease category, any age, if ineligible for myeloablative conditioning because of organ dysfunction or advanced age (55 years or older). Minimum organ function for patients entered on this protocol defined as: Cardiac: Ejection fraction at least 30%. Renal: Creatinine <1.5 times normal for age. Pulmonary: FEV1 and FVC >60%. Hepatic: Total bilirubin <2.0 and AST/ALT <3 X institutional normal for age. Performance (adults): Karnofsky score must be at least 60; for pts. under 16, Lansky score must be at least 60. Low grade lymphoma (small lymphocytic, follicular small cleaved cell, or follicular mixed small cleaved and large cell) must meet the following criteria: any age relapsed or refractory disease provided the disease is NOT rapidly progressive no lymphoma mass or lymph node exceeds 5 cm in greatest dimension Age: no age restriction Availability of a 6/6 HLA A, B, and DR identical relative who is willing and able to donate allogeneic stem cells No active infection Serum creatinine less than 1.5 times normal for age Serum bilirubin less than 1.5 times normal for age Not pregnant. Patient Exclusion Criteria: HIV positive patients not eligible Pregnant Donor Inclusion Criteria: 6/6 HLA match for HLA-A, B, and DR Age 3-70 years, good general health No contraindication to G-CSF stimulation No contraindication to leukapheresis of peripheral blood stem cells Good general health Donor Exclusion Criteria: HIV positive or history of HIV risk factors Presence of other diseases transmissible by blood that pose unacceptable risk to the study subject. Pregnant Medical or psychological conditions that would make the donor unlikely to tolerate G-CSF injections or leukapheresis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John E. Levine, MS MD
Organizational Affiliation
The Univeristy of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Low Intensity Conditioning and Immunotherapy for High-Risk Cancers of the Blood

We'll reach out to this number within 24 hrs