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| Sponsor: | Baylor College of Medicine |
|---|---|
| Collaborators: |
Texas Children's Hospital The Methodist Hospital System Center for Cell and Gene Therapy, Baylor College of Medicine National Heart, Lung, and Blood Institute (NHLBI) |
| Information provided by: | Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00710892 |
Purpose
This Phase I trial is designed to determine the number of suicide gene-modified allodepleted donor lymphocytes that can be given to recipients of haploidentical stem cell transplants resulting in 25% or less developing grade 3 or 4 GVHD.
The exact number of patients required for the study is not known as this is a Phase I trial but the investigators will require anywhere between 3 to 18 patients for the whole study. The accrual rate is expected to be about 8 patients per year. There is no randomization and no control group.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Lymphoblastic Leukemia Non-Hodgkin's Lymphoma |
Biological: Allodepleted T Cells |
Phase I |
| 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: | CASPALLO: Allodepleted T Cells Transduced With Inducible Caspase 9 Suicide Gene After Haploidentical Stem Cell Transplantation |
| Estimated Enrollment: | 18 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | August 2028 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dose Level 1-3 |
Biological: Allodepleted T Cells
Dose Level 1: 1 x 10exp6 T cells/Kg Dose Level 2: 3 x 10exp6 T cells/Kg Dose Level 3: 1 x 10exp7 T cells/Kg Patients may be enrolled on the next dose level of T cells when all patients on the previous dose level have reached Day 40 days following initial -T cell infusion without unacceptable toxicity. |
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At the time of transplant:
Patients (up to 65 years of age) with:
Lack of suitable conventional donor (i.e. 5/6 or 6/6 related or 5/6 or 6/6 unrelated donor) or presence of a rapidly progressive disease not permitting time to identify an unrelated donor.
Inclusion Criteria at time of allodepleted T cell infusion:
Exclusion Criteria:
At the time of transplant: - Pregnant*
At the time of allodepleted T cell infusion:
Other investigational drugs in the prior 30 days
Contacts and Locations| United States, Texas | |
| Texas Children's Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Malcolm Brenner, MB, PhD 832-824-4671 mkbrenne@txccc.org | |
| Contact: Helen Heslop, MD 832-824-4662 heheslop@txccc.org | |
| Principal Investigator: Malcolm Brenner, MB, PhD | |
| Sub-Investigator: George Carrum, MD | |
| Sub-Investigator: Bambi J Grilley | |
| Sub-Investigator: Robert A Krance, MD | |
| Sub-Investigator: Helen E Heslop, MD | |
| Sub-Investigator: Cliona M Rooney, MD | |
| Sub-Investigator: Adrian P Gee, MD | |
| Sub-Investigator: Stephen M Gottschalk, MD | |
| Sub-Investigator: Kathryn S Leung, MD | |
| Sub-Investigator: Gianpietro Dotti, MD | |
| Sub-Investigator: Catherine M Bollard, MD | |
| Sub-Investigator: Nabil M Ahmed, MD | |
| Sub-Investigator: Alana A Kennedy-Nasser, MD | |
| Sub-Investigator: Antonio Distasi, MD | |
| Sub-Investigator: Rammurti T Kamble, MD | |
| Sub-Investigator: Hao Liu | |
| Sub-Investigator: Caridad Martinez, MD | |
| The Methodist Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: George Carrum, MD 713-394-6250 gcarrum@bcm.edu | |
| Sub-Investigator: George Carrum, MD | |
| Sub-Investigator: Malcolm Brenner, MD, PhD | |
| Sub-Investigator: Helen E Heslop, MD | |
| Sub-Investigator: Rammurti Kamble, MD | |
| Texas Children's Cancer Center GCRC | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Helen Heslop, MD 832-824-4662 heheslop@txccc.org | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Malcolm K Brenner, MD 832-824-4671 mbrenner@bcm.tmc.edu | |
| Principal Investigator: | Malcolm Brenner, MD | Baylor College of Medicine |
More Information
| Responsible Party: | Malcolm Brenner, Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00710892 History of Changes |
| Other Study ID Numbers: | 21580-CASPALLO |
| Study First Received: | July 3, 2008 |
| Last Updated: | August 12, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
suicide gene-modified allodepleted donor lymphocytes given to recipients of haploidentical stem cell transplants Stage III Stage IV Myelodysplastic syndrome AML after first relapse primary refractory disease |
CML Hemophagocytic lymphohistiocytosis (HLH) familial hemophagocytic lymphohistiocytosis (FLH) viral-associated hemophagocytic syndrome (VAHS) Severe chronic active Epstein Barr virus infection (SCAEBV) T or NK cell malignancy X-linked lymphoproliferative disease (XLP) |
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphohistiocytosis, Hemophagocytic Lymphoma Lymphoma, Non-Hodgkin Suicide Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Histiocytosis, Non-Langerhans-Cell Histiocytosis Self-Injurious Behavior Behavioral Symptoms |