N/A N=18 Treatment

Chemotherapy Followed by Allogeneic Stem Cell Transplantation for Hematologic Malignancies

Hematologic Malignancies

Bottom Line

View on ClinicalTrials.gov: NCT00741455 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Nov 2020

Primary outcome: Primary: Number of Participants With Successful Bone Marrow Engraftment — 1; 15; 1 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Stem Cell Transplant (Procedure); G-CSF (Drug); Fludarabine (Drug); cyclophosphamide (Drug); Cyclosporine (Drug); Methotrexate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Dartmouth-Hitchcock Medical Center
Primary completion: May 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Successful Bone Marrow Engraftment	1; 15; 1	—
SECONDARY Number of Participants Who Achieve Complete Donor Chimerism	2; 2; 3; 3; 4; 1	—
SECONDARY Number of Participants Who Experienced Graft-Versus-Host-Disease	—	—
SECONDARY Overall Survival Measured in Participants	2; 8; 0; 7	—
SECONDARY Collection of Adverse Events	—	—
SECONDARY Assess Disease Response	—	—

Summary

The purpose of this study is to determine disease-free survival, overall survival, time to progression, regimen-related toxicity and/or treatment-related mortality in patients with hematologic malignancies treated with non-myeloablative chemotherapy followed by allogeneic stem cell transplant.

Eligibility Criteria

Inclusion Criteria

Age: 18-75 years
Diseases
Chronic myelogenous leukemia (CML)
First chronic phase or later
Accelerated phase
Acute myelogenous or lymphoblastic leukemia (AML or ALL)
Second or subsequent remission
Patients who have failed an autologous PBSC transplant
First remission with poor risk features, including, but not limited to: For AML- complex chromosome karyotype, abnormalities of chromosome 5 or 7, 12p-, 13+, 8+, t(9;22), t(11;23) For ALL- t(9;22), t(4;11), t(1;19), myeloid antigen coexpression
Myelodysplastic syndrome (MDS)
Multiple myeloma - high risk myeloma (poor responders, relapse after autologous PBSCT, chromosome 13 abnormalities)
Hodgkin's disease
Primary refractory disease
Relapsed disease (first relapse or later)
Patients who have failed an autologous PBSC transplant
Non-Hodgkin's lymphoma Low grade (by Working Formulation)
Relapsed, progressive disease after initial chemotherapy
Primary refractory disease or failure to respond (>PR) to initial chemotherapy
Patients who have failed an autologous PBSC transplant Intermediate grade (by Working Formulation)
Relapsed disease
Primary refractory disease or failure to respond (>PR) to initial chemo
Mantle cell lymphoma
Patients who have failed an autologous PBSC transplant
Chronic lymphocytic leukemia (CLL)
Patients newly diagnosed with poor prognostic factors, including CD38 expression, Chromosome 11 or 17 abn
T-CLL/PLL
Relapsed or progressive disease, or refractory after Fludarabine
Patients who have failed an autologous PBSC transplant
Donor Availability: Six of six matched HLA A, B and DR identical sibling (or parent or child) or 5/6 related donor with single mismatch at Class I antigen (A or B)
Karnofsky performance status of >70%
Serum bilirubin 40 ml/min.
DLCO >50% predicted
Left ventricular ejection fraction >35%
No active infection
Non-pregnant female
Signed informed consent
No major organ dysfunction or psychological problems that preclude compliance and completion of the clinical trial.

Exclusion Criteria

Major organ dysfunction
Pregnant or lactating female
Active infection
Psychological problems that preclude compliance and completion of the clinical trial
Any other condition, that in the judgement of the investigator, affects participant safety or overall participation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00741455). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.