- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01272817
Nonmyeloablative Allogeneic Transplant (Mini-allo)
November 21, 2022 updated by: Scripps Health
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using Antithymocyte Globulin With Either Melphalan and Cladribine or Total Lymphoid Irradiation
Allogeneic transplant from a matched sibling for the treatment of a variety of illnesses including bone marrow failure states, leukemias, myelodysplastic or myeloproliferative syndromes, lymphoma, or myeloma using a nonmyeloablative preparative regimen.
Study Overview
Status
Completed
Conditions
- Melanoma
- Sarcoma
- Renal Cell Carcinoma
- Breast Cancer
- Multiple Myeloma
- Hodgkin's Lymphoma
- Non-Hodgkin's Lymphoma
- Ovarian Cancer
- Thymoma
- Waldenstrom Macroglobulinemia
- Mantle Cell Lymphoma
- Chronic Lymphocytic Leukemia
- Myelodysplastic Syndrome
- Acute Lymphocytic Leukemia
- Acute Myelogenous Leukemia
- Chronic Myelogenous Leukemia
- Aplastic Anemia
- Paroxysmal Nocturnal Hemoglobinuria
Intervention / Treatment
Detailed Description
same
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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La Jolla, California, United States, 92037
- Scripps Green Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 72 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age > 55 years or
- Age < 55 and LVEF < 45% or creatinine clearance < 60 ml/min
- Ability to cover the cost of the transplant, necessary medications, and transportation/housing.
- Caregiver must be available while outpatient
Guidelines for Cladribine-Melphalan-based conditioning:
- Bone Marrow Failure States Severe Aplastic Anemia (relapsed following immunosuppressive therapy) Paroxysmal Nocturnal Hemoglobinuria (poor prognostic features or hemosiderosis)
- AML (first CR except for t(15;17), inv16, t(8,21); second CR; relapse failing second induction attempt)
- ALL (first CR with at least one poor prognostic feature; second or greater CR; relapse failing reinduction attempt)
- MDS (RAEB, RAEBiT, CMMoL)
- CML (chronic phase; accelerated phase; blast phase following reinduction attempt; 2nd chronic or accelerated phase following gleevec therapy
- Hodgkin's lymphoma (first or greater relapse)
- Non-Hodgkin's Lymphoma
- Aggressive Histology (includes T Cell NHL) Incomplete response to induction Second CR Sensitive or refractory relapse
- Indolent Histology Second or greater relapse
- Mantle Cell Lymphoma (any Stage - must have received induction chemotherapy)
- Multiple Myeloma (10% residual plasmacytosis following anthracycline-based chemotherapy or residual disease following autologous transplant)
- Waldenstrom Macroglobulinemia (must have failed either purine analogue-based chemotherapy (Fludara or 2CdA) or standard CVP therapy; hyperviscosity or cytopenias)
Guidelines for total lymphoid irradiation-based conditioning
- MDS (RA, RARS)
- CLL (Rai stage III or IV - must have received at least two different treatment regimens in the past)
- Breast Cancer (symptomatic metastatic disease, who have failed standard chemotherapy)
- Renal Cell Cancer (metastatic disease at multiple sites)
- Malignant Melanoma (metastatic disease at multiple sites)
- Sarcoma (all subtypes presently, unresectable metastatic disease)
- Ovarian Cancer (stage III or IV, platinum insensitive disease, i.e. progression within 6 months of initial platinum chemotherapy)
- Thymoma (unresectable disease)
Exclusion Criteria:
- Prior allogeneic stem cell or bone marrow transplant
- Current or past history of invasive mycotic infection
- Breast Feeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Cladribine + melphalan
Cladribine + melphalan conditioning
|
Cladribine 0.14 mg/kg/day for five days, melphalan 100 mg/m2 on one day
Total lymphoid irradiation 100cGy/day times 10 days (Monday through Friday)
|
Other: TLI
Total lymphoid irradiation conditioning
|
Cladribine 0.14 mg/kg/day for five days, melphalan 100 mg/m2 on one day
Total lymphoid irradiation 100cGy/day times 10 days (Monday through Friday)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Engraftment
Time Frame: One year
|
Evaluation of engraftment of donor stem cells by bone marrow examinations at days 30, 100, and 360 after transplant.
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Graft-versus-host disease
Time Frame: One year
|
Assess the incidence and severity of acute and/or chronic GVHD for patients transplanted on this protocol.
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeffrey W. Andrey, M.D., Scripps Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2001
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
January 6, 2011
First Submitted That Met QC Criteria
January 7, 2011
First Posted (Estimate)
January 10, 2011
Study Record Updates
Last Update Posted (Actual)
November 23, 2022
Last Update Submitted That Met QC Criteria
November 21, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Neoplasms by Site
- Urologic Diseases
- Urological Manifestations
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Myeloproliferative Disorders
- Thoracic Neoplasms
- Urination Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Anemia
- Neoplasms, Plasma Cell
- Neoplasms, Complex and Mixed
- Leukemia, B-Cell
- Proteinuria
- Anemia, Hemolytic
- Bone Marrow Failure Disorders
- Thymus Neoplasms
- Lymphoma
- Myelodysplastic Syndromes
- Multiple Myeloma
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Thymoma
- Lymphoma, Mantle-Cell
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Waldenstrom Macroglobulinemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Anemia, Aplastic
- Hemoglobinuria
- Hemoglobinuria, Paroxysmal
Other Study ID Numbers
- IRB#13-6255
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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