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CD34+Selection for Partially Matched Family or Matched Unrelated Adult Donor Transplant

Primary Purpose

Leukemia, Lymphoma, Bone Marrow Failure

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Full Intensity with TBI

Full Intensity

Reduced Intensity

Reduced Intensity (Fanconi)

About this trial

This is an interventional treatment trial for Leukemia focused on measuring unrelated donor transplant, CD34 selection

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adequate renal function defined as:Serum creatinine <1.5 x normal, or Creatinine clearance or radioisotope GFR >60 ml/min/m2 or an equivalent GFR as determined by the institutional normal range.
Adequate liver function defined as:Total bilirubin <1.5 x normal, or SGOT (AST) or SGPT (ALT) <3.0 x normal
Adequate cardiac function defined as:Shortening fraction >27% by echocardiogram, or Ejection fraction of >47% by radionucleotide angiogram or echocardiogram.
Adequate pulmonary function defined as:Uncorrected DLCO >50% by pulmonary function test. For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% on room air.

Eligibility for Reduced Intensity Regimen:

Adequate renal function defined as:Serum creatinine 2.0 x normal, or creatinine clearance or radioisotope GFR > 40 ml/min/m2 or an equivalent GFR as determined by the institutional normal range.
Adequate liver function defined as:Total bilirubin < 2.5 x normal; or SGOT (AST) or SGPT (ALT) < 5.0 x normal.
Adequate cardiac function defined as:Shortening fraction of >25% by echocardiogram, or Ejection fraction of >40% by radionuclide angiogram or echocardiogram.
Adequate pulmonary function defined as:DLCO >35% by pulmonary function test. For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% in room air.

Exclusion Criteria:

Pregnancy/Breast Feeding: Females who are pregnant or breast-feeding are not eligible.
Infection: Patients with documented uncontrolled infection at the time of study entry are not eligible.

Sites / Locations

New York Medical College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Thiotepa/Cyclophosphamide/ATG

Busulfan/Melphalan/ATG

Busulfan/Fludarabine/Alemtuzumab

Fludarabine/Cyclophosphamide/ATG

Arm Description

Full intensity with TBI

Full intensity without TBI

Reduced Intensity Chemotherapy

Reduced Intensity Chemotherapy for Fanconi Anemia

Outcomes

Primary Outcome Measures

The safety CD34+ stem cell selection

serious adverse events will be monitored post transplant to determine if there is an increase vs. historical data related to the CD34+ selection

Secondary Outcome Measures

Immune reconstitution (T, B, DC) following CD34+ selection

immune subsets will be drawn post transplant to determine the rate of reconstitution post CD34+ transplant to determine if this process increases or decreases the reconstitution time.

Full Information

NCT ID

NCT01049854

First Posted

May 5, 2008

Last Updated

August 20, 2018

Sponsor

New York Medical College

1. Study Identification

Unique Protocol Identification Number

NCT01049854

Brief Title

CD34+Selection for Partially Matched Family or Matched Unrelated Adult Donor Transplant

Official Title

CD34+Stem Cell Selection for Patients Receiving Partially Matched Family or Matched Unrelated Adult Donor Allogeneic Stem Cell Transplantations for Malignant and Non-Malignant Disease

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

November 2017 (Actual)

Study Completion Date

August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York Medical College

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

CD34+ stem cell selection in children, adolescents and young adults receiving partially matched family donor or matched unrelated adult donor allogeneic bone marrow or peripheral blood stem cell transplant will be safe and well tolerated and be associated with a low incidence of serious (Grade III/IV) acute and chronic graft versus host disease (GVHD).

Detailed Description

The selection of CD34+ cells is associated with the simultaneous depletion of T cells that are responsible for severe acute and chronic graft versus host disease (GVHD). Successful engraftment is reported in adult patients with malignant and non-malignant disease who received CD34+ selected stem cells from HLA-matched or mismatched mobilized peripheral blood (PBSC) or bone marrow. Study Design: Selected patients defined in the eligibility criteria will enrolled on this study. Patients will receive one of either full intensity or reduced intensity regimen based on the patient's disease status, organ function and performance and determined by the PI and will have peripheral blood undergo CD34 selection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Lymphoma, Bone Marrow Failure, Immunodeficiencies, Histiocytosis, Sickle Cell Disease, Beta Thalassemia, Inborn Errors of Metabolism

Keywords

unrelated donor transplant, CD34 selection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Thiotepa/Cyclophosphamide/ATG

Arm Type

Experimental

Arm Description

Full intensity with TBI

Arm Title

Busulfan/Melphalan/ATG

Arm Type

Experimental

Arm Description

Full intensity without TBI

Arm Title

Busulfan/Fludarabine/Alemtuzumab

Arm Type

Experimental

Arm Description

Reduced Intensity Chemotherapy

Arm Title

Fludarabine/Cyclophosphamide/ATG

Arm Type

Experimental

Arm Description

Reduced Intensity Chemotherapy for Fanconi Anemia

Intervention Type

Drug

Intervention Name(s)

Full Intensity with TBI

Other Intervention Name(s)

ThioTepa, Cytoxan, Atgam

Intervention Description

Patients will start their pre-conditioning regimen on Day -8. Fractionated TBI will be administered twice daily for 3 days on Days -8, -7, and -6. Patients will receive Thiotepa on Days -5, -4, Cyclophosphamide on Days -3, -2 and rabbit antithymocyte globulin on Days -4, -3, -2 and -1. The stem cell infusion will be performed on Day 0. GM-CSF hematopoietic growth factor will start on Day 0. GVHD prophylaxis will consist of tacrolimus only.

Intervention Type

Drug

Intervention Name(s)

Full Intensity

Other Intervention Name(s)

Myleran, Alkeran, Atgam

Intervention Description

Patients will start their pre-conditioning regimen on Day -9. Patients will receive busulfan twice daily on Days - 8, -7, -6, and -5 and Melphalan on Days -4, -3 and -2 and rabbit antithymocyte globulin on Days -4, -3, -2 and -1 with stem cell infusion on Day 0. GM-CSF hematopoietic growth factor will start on Day 0. GVHD prophylaxis will consist of tacrolimus only.

Intervention Type

Drug

Intervention Name(s)

Reduced Intensity

Other Intervention Name(s)

Fludara, Myleran, Campath

Intervention Description

Patients will start their GVHD prophylaxis with Tacrolimus on Day -9. Patients will receive busulfan twice daily on Days -8, -7, -6, and -5; fludarabine on Days -7, -6, -5, -4, -3 and -2 and alemtuzumab on Days -5, -4, -3, -2, and -1. The stem cell infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus only.

Intervention Type

Drug

Intervention Name(s)

Reduced Intensity (Fanconi)

Other Intervention Name(s)

Fludara, Cytoxan, Atgam

Intervention Description

Patients will start their pre-conditioning regimen on Day -6. Patients will receive TBI as a single fraction on Day -6. Patients will receive fludarabine and cyclophosphamide on Days - 5, -4, -3, and -2 and antithymocyte globulin (horse) on Days -5, -4, -3, -2 and -1. The stem cell infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus only.

Primary Outcome Measure Information:

Title

The safety CD34+ stem cell selection

Description

serious adverse events will be monitored post transplant to determine if there is an increase vs. historical data related to the CD34+ selection

Time Frame

100 days

Secondary Outcome Measure Information:

Title

Immune reconstitution (T, B, DC) following CD34+ selection

Description

immune subsets will be drawn post transplant to determine the rate of reconstitution post CD34+ transplant to determine if this process increases or decreases the reconstitution time.

Time Frame

3 years

10. Eligibility

Sex

All

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adequate renal function defined as:Serum creatinine <1.5 x normal, or Creatinine clearance or radioisotope GFR >60 ml/min/m2 or an equivalent GFR as determined by the institutional normal range. Adequate liver function defined as:Total bilirubin <1.5 x normal, or SGOT (AST) or SGPT (ALT) <3.0 x normal Adequate cardiac function defined as:Shortening fraction >27% by echocardiogram, or Ejection fraction of >47% by radionucleotide angiogram or echocardiogram. Adequate pulmonary function defined as:Uncorrected DLCO >50% by pulmonary function test. For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% on room air. Eligibility for Reduced Intensity Regimen: Adequate renal function defined as:Serum creatinine 2.0 x normal, or creatinine clearance or radioisotope GFR > 40 ml/min/m2 or an equivalent GFR as determined by the institutional normal range. Adequate liver function defined as:Total bilirubin < 2.5 x normal; or SGOT (AST) or SGPT (ALT) < 5.0 x normal. Adequate cardiac function defined as:Shortening fraction of >25% by echocardiogram, or Ejection fraction of >40% by radionuclide angiogram or echocardiogram. Adequate pulmonary function defined as:DLCO >35% by pulmonary function test. For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% in room air. Exclusion Criteria: Pregnancy/Breast Feeding: Females who are pregnant or breast-feeding are not eligible. Infection: Patients with documented uncontrolled infection at the time of study entry are not eligible.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mitchell S Cairo, MD

Organizational Affiliation

New York Medical College

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York Medical College

City

Valhalla

State/Province

New York

ZIP/Postal Code

10595

Country

United States

12. IPD Sharing Statement

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CD34+Selection for Partially Matched Family or Matched Unrelated Adult Donor Transplant

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