Nonmyeloablative Allogeneic Transplant

Breast Cancer Clinical Trial

— Mini-allo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272817
• Other study ID #: IRB#13-6255
• Status: Completed
• Phase: N/A
• Start date: October 2001
• Est. completion date: October 2015

Study information

• Verified date: November 2022
• Source: Scripps Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

same

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphocytic Leukemia
• Acute Myelogenous Leukemia
• Anemia, Aplastic
• Aplastic Anemia
• Breast Cancer
• Chronic Lymphocytic Leukemia
• Chronic Myelogenous Leukemia
• Hemoglobinuria
• Hemoglobinuria, Paroxysmal
• Hodgkin's Lymphoma
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma
• Melanoma
• Multiple Myeloma
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Non-Hodgkin's Lymphoma
• Ovarian Cancer
• Paroxysmal Nocturnal Hemoglobinuria
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Renal Cell Carcinoma
• Sarcoma
• Thymoma
• Waldenstrom Macroglobulinemia

Intervention

Procedure:
• Nonmyeloablative Allogeneic Transplant
Cladribine 0.14 mg/kg/day for five days, melphalan 100 mg/m2 on one day
• Nonmyeloablative Allogeneic Transplant
Total lymphoid irradiation 100cGy/day times 10 days (Monday through Friday)

Locations

Country	Name	City	State
United States	Scripps Green Hospital	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engraftment	Evaluation of engraftment of donor stem cells by bone marrow examinations at days 30, 100, and 360 after transplant.	One year
Secondary	Graft-versus-host disease	Assess the incidence and severity of acute and/or chronic GVHD for patients transplanted on this protocol.	One year