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Nonmyeloablative Allogeneic Transplant (Mini-allo)

Primary Purpose

Aplastic Anemia, Paroxysmal Nocturnal Hemoglobinuria, Acute Myelogenous Leukemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nonmyeloablative Allogeneic Transplant
Nonmyeloablative Allogeneic Transplant
Sponsored by
Scripps Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aplastic Anemia focused on measuring Nonmyeloablative transplant, Allogeneic transplant, Transplant

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scripps Green Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Cladribine + melphalan

TLI

Arm Description

Cladribine + melphalan conditioning

Total lymphoid irradiation conditioning

Outcomes

Primary Outcome Measures

Engraftment
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
Assess the incidence and severity of acute and/or chronic GVHD for patients transplanted on this protocol.

Full Information

First Posted
January 6, 2011
Last Updated
November 21, 2022
Sponsor
Scripps Health
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1. Study Identification

Unique Protocol Identification Number
NCT01272817
Brief Title
Nonmyeloablative Allogeneic Transplant
Acronym
Mini-allo
Official Title
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using Antithymocyte Globulin With Either Melphalan and Cladribine or Total Lymphoid Irradiation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scripps Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
same

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Nonmyeloablative transplant, Allogeneic transplant, Transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cladribine + melphalan
Arm Type
Other
Arm Description
Cladribine + melphalan conditioning
Arm Title
TLI
Arm Type
Other
Arm Description
Total lymphoid irradiation conditioning
Intervention Type
Procedure
Intervention Name(s)
Nonmyeloablative Allogeneic Transplant
Intervention Description
Cladribine 0.14 mg/kg/day for five days, melphalan 100 mg/m2 on one day
Intervention Type
Procedure
Intervention Name(s)
Nonmyeloablative Allogeneic Transplant
Intervention Description
Total lymphoid irradiation 100cGy/day times 10 days (Monday through Friday)
Primary Outcome Measure Information:
Title
Engraftment
Description
Evaluation of engraftment of donor stem cells by bone marrow examinations at days 30, 100, and 360 after transplant.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Graft-versus-host disease
Description
Assess the incidence and severity of acute and/or chronic GVHD for patients transplanted on this protocol.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey W. Andrey, M.D.
Organizational Affiliation
Scripps Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Green Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

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Nonmyeloablative Allogeneic Transplant

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