Trial record 9 of 19 for:    Open Studies | "Thymus Neoplasms"

Nonmyeloablative Allogeneic Transplant (Mini-allo)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Scripps Health
Sponsor:
Information provided by (Responsible Party):
Jeffrey Andrey, MD, Scripps Health
ClinicalTrials.gov Identifier:
NCT01272817
First received: January 6, 2011
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Aplastic Anemia
Paroxysmal Nocturnal Hemoglobinuria
Acute Myelogenous Leukemia
Acute Lymphocytic Leukemia
Myelodysplastic Syndrome
Chronic Myelogenous Leukemia
Chronic Lymphocytic Leukemia
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Mantle Cell Lymphoma
Multiple Myeloma
Waldenstrom Macroglobulinemia
Breast Cancer
Renal Cell Carcinoma
Melanoma
Sarcoma
Ovarian Cancer
Thymoma
Procedure: Nonmyeloablative Allogeneic Transplant

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: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using Antithymocyte Globulin With Either Melphalan and Cladribine or Total Lymphoid Irradiation

Resource links provided by NLM:


Further study details as provided by Scripps Health:

Primary Outcome Measures:
  • Engraftment [ Time Frame: One year ] [ Designated as safety issue: No ]
    Evaluation of engraftment of donor stem cells by bone marrow examinations at days 30, 100, and 360 after transplant.


Secondary Outcome Measures:
  • Graft-versus-host disease [ Time Frame: One year ] [ Designated as safety issue: No ]
    Assess the incidence and severity of acute and/or chronic GVHD for patients transplanted on this protocol.


Estimated Enrollment: 50
Study Start Date: October 2001
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cladribine + melphalan
Cladribine + melphalan conditioning
Procedure: Nonmyeloablative Allogeneic Transplant
Cladribine 0.14 mg/kg/day for five days, melphalan 100 mg/m2 on one day
TLI
Total lymphoid irradiation conditioning
Procedure: Nonmyeloablative Allogeneic Transplant
Total lymphoid irradiation 100cGy/day times 10 days (Monday through Friday)

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 55 years or
  2. Age < 55 and LVEF < 45% or creatinine clearance < 60 ml/min
  3. Ability to cover the cost of the transplant, necessary medications, and transportation/housing.
  4. 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:

  1. Prior allogeneic stem cell or bone marrow transplant
  2. Current or past history of invasive mycotic infection
  3. Breast Feeding
  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: NCT01272817

Contacts
Contact: Carol Burian 858-554-2845 burian.carol@scrippshealth.org

Locations
United States, California
Scripps Green Hospital Recruiting
La Jolla, California, United States, 92037
Contact: Cynthia Nelson, R.N.    858-554-2814    nelson.cynthia@scrippshealth.org   
Contact: Laurie Cobarrubia, R.N.    858-554-2853    cobarrubia.laurie@scrippshealth.org   
Principal Investigator: Jeffrey W. Andrey, M.D.         
Sub-Investigator: James R. Mason, M.D.         
Sub-Investigator: William E. Miller, M.D.         
Sponsors and Collaborators
Scripps Health
Investigators
Principal Investigator: Jeffrey W. Andrey, M.D. Scripps Health
  More Information

No publications provided

Responsible Party: Jeffrey Andrey, MD, Director, Unrelated Donor Transplantation, Scripps Health
ClinicalTrials.gov Identifier: NCT01272817     History of Changes
Other Study ID Numbers: IRB#13-6255
Study First Received: January 6, 2011
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Scripps Health:
Nonmyeloablative transplant
Allogeneic transplant
Transplant

Additional relevant MeSH terms:
Thymoma
Thymus Neoplasms
Anemia
Anemia, Aplastic
Breast Neoplasms
Carcinoma
Carcinoma, Renal Cell
Hemoglobinuria
Hodgkin Disease
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma
Lymphoma, Non-Hodgkin
Waldenstrom Macroglobulinemia
Hemoglobinuria, Paroxysmal
Melanoma
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Ovarian Neoplasms
Lymphoma, Mantle-Cell
Sarcoma
Hematologic Diseases
Bone Marrow Diseases

ClinicalTrials.gov processed this record on August 28, 2014