NCT00741455 · REGISTRY CONDITION SEARCH

Chemotherapy Followed by Allogeneic Stem Cell Transplantation for Hematologic Malignancies

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2020-11-23

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Number of Participants With Successful Bone Marrow Engraftment

→

outcome · POSTED

Number of Participants Who Achieve Complete Donor Chimerism

→

outcome · POSTED

Number of Participants Who Experienced Graft-Versus-Host-Disease

→

outcome · POSTED

Overall Survival Measured in Participants

→

outcome · POSTED

Collection of Adverse Events

→

outcome · POSTED

Assess Disease Response

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria: * Age: 18-75 years * Diseases 1. Chronic myelogenous leukemia (CML) * First chronic phase or later * Accelerated phase 2. 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 3. Myelodysplastic syndrome (MDS) 4. Multiple myeloma - high risk myeloma (poor responders, relapse after autologous PBSCT, chromosome 13 abnormalities) 5. Hodgkin's disease * Primary refractory disease * Relapsed disease (first relapse or later) * Patients who have failed an autologous PBSC transplant 6. 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 7. 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 \<2x upper limit of normal; transaminases \<3x normal (unless due to disease) * 24 hr urine creatinine clearance of \>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
healthy Volunteers: false
maximum Age: 75 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Chemotherapy, stem cell transplantation, HLA-Matched related allogeneic stem cell transplantation, leukapheresis, G-CSF, peripheral blood stem cell transplant, fludarabine, cyclophosphamide, donor lymphocyte infusion, cyclosporine, methotrexate
intervention Names
Procedure: Stem Cell Transplant
Drug: G-CSF
Drug: Fludarabine
Drug: cyclophosphamide
Drug: Cyclosporine
Drug: Methotrexate
label
Study Treatment
type
EXPERIMENTAL

interventions

arm Group Labels
Study Treatment
description
Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be \> 5 x 106 CD34+cells/kg of recipient. Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later. Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml.
name
Stem Cell Transplant
other Names
HLA-Matched Related Allogeneic Stem Cell Transplantation
type
PROCEDURE
arm Group Labels
Study Treatment
description
10 mcg/kg/day on days 5, 6, and 7
name
G-CSF
type
DRUG
arm Group Labels
Study Treatment
description
25 mg/m2/d IV over 30 minutes on days -6 to -2
name
Fludarabine
type
DRUG
arm Group Labels
Study Treatment
description
1 g/m2/d IV on days -3 and -2
name
cyclophosphamide
type
DRUG
arm Group Labels
Study Treatment
description
used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml
name
Cyclosporine
type
DRUG
arm Group Labels
Study Treatment
description
used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml
name
Methotrexate
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 18
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Rates of successful engraftment.
measure
Number of Participants With Successful Bone Marrow Engraftment
time Frame
Within 30 days of bone marrow transplant

secondary Outcomes

description
Complete donor chimerism
measure
Number of Participants Who Achieve Complete Donor Chimerism
time Frame
Post-transplant days +30, +60, +100, +180 and +365
description
Collect the number of incidents of acute and chronic graft-versus-host disease
measure
Number of Participants Who Experienced Graft-Versus-Host-Disease
time Frame
Post-transplant procedure through death
description
Mortality rates in subjects after successful completion of a bone marrow transplant
measure
Overall Survival Measured in Participants
time Frame
Up to 15 Years Post-Transplant
description
Determine the level of toxicity experienced by subjects who receive protocol treatment and bone marrow transplant
measure
Collection of Adverse Events
time Frame
Until the 6th Bone Marrow Transplant performed in subjects on study
description
Review and assess the tumor response rate
measure
Assess Disease Response
time Frame
Post-transplant procedure through death

Full study description

brief 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.
detailed Description: Allogeneic bone marrow transplantation (BMT) became feasible in the 1960s after elucidation of the Human Leukocyte Antigen (HLA) complex. Since then, the therapy has evolved into an effective treatment for many hematologic disorders. Otherwise incurable malignancies are frequently cured by this approach, with the likelihood of cure ranging from 10% to 85%, depending on the disease and the disease status. The treatment strategy incorporates very large doses of chemotherapy and often radiation to eliminate cancer cells and to immunosuppress the recipient to allow the engraftment of donor cells. Donor cells give rise to hematopoiesis within two to three weeks, rescuing the patient from the effects of high dose therapy. In the ideal situation, immune recovery and recipient-specific tolerance occurs over the following 6-18 months, and the patient is cured of their underlying malignancy, off immunosuppression, with a functionally intact donor-derived immune system. However, complications are common and include fatal organ damage from the effects of high dose chemotherapy, infection, hemorrhage, and, in particular, graft-versus-host disease (GvHD). A realistic estimate of transplant-related mortality in the standard HLA-matched sibling setting is approximately 25%. The risk of treatment-related mortality limits the success and certainly precludes its use in older patients. Thus, new strategies in transplantation are needed. With the growing understanding that much of the curative potential of allogeneic bone marrow or stem cell transplant (SCT) is from an immune anti-tumor effect of donor cells, known as graft-versus-leukemia (GvL) or graft-versus-tumor (GvT), a new strategy is being employed that shifts the emphasis from high-dose chemo-radiotherapy to donor-derived, immune-mediated anti-tumor therapy. In this approach, patients receive preparative regimens that, while having some anti-tumor activity, are mainly designed to be immunosuppressive enough to allow engraftment of donor stem cells and lymphocytes. Engrafted lymphocytes then mediate a GvL effect; if the GvL effect of the initial transplant is not sufficient, then additional lymphocytes may be infused (achievement of engraftment allows additional lymphocytes to "take" in the recipient without requiring any additional conditioning of the recipient). The lower intensity of the preparative regimen lessens the overall toxicity by minimizing the doses of chemo-radiotherapy. In addition, less intensive preparative regimens may be associated with less GvHD, as much evidence suggests that high-dose therapy contributes to the syndrome of GvHD by causing tissue damage, leading to a cytokine milieu which enhances activation of graft-versus-host (GvH) effector cells. Thus, such an approach may allow the safer use of allogeneic transplants in standard populations and may allow extension of allogeneic transplantation to patients who could not receive standard (myeloablative) transplants because of age or co-morbidities. This protocol investigates a non-myeloablative transplant approach, using fludarabine and cyclophosphamide, to allow engraftment of allogeneic cells, which may then mediate anti-tumor effects.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-73a1cee194dbb0b2120e
requested nct id
NCT00741455
primary nct id
NCT00741455
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
payload sha256
9bde66a0b097d18aa0be429ead92f22bd928805ddbe8eca976cfcf163872b322
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-73a1cee194dbb0b2120e
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00741455
occurrences
context exact
NCT00741455
end
11
exact text
NCT00741455
start
0
offset unit
unicode_code_points
query cond
Plasma Cell Neoplasms
query disease state id
ds-plasma-cell-neoplasms
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
source json pointer
/studies/746/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
d196c069b2352571ebd1f9d9433ee5fc6f8ee24bec2b098c697d202e9ee19349
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice