NCT00143845 · REGISTRY CONDITION SEARCH

Study of Low-Intensity Conditioning for Allogeneic Stem Cell Transplant

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

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2017-03-08

The purpose of this study is to determine whether a reduced intensity conditioning regimen for stem cell transplant with donor cells will allow the donor cells to be effective without causing health problems.

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

Percentage of Participants With Acute Graft Versus Host Disease (GVHD) Grades 2-4

→

outcome · POSTED

Percentage of Participants With Progression Free Survival

→

outcome · POSTED

Percentage of Patients Alive at 2 Years

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Patient Inclusion Criteria: To be eligible a patient MUST meet at least one of the next 4 criteria * Any patient aged 55 years or older with a hematological malignancy for which allogeneic transplant is considered an appropriate treatment, AND/OR * Any patient, regardless of age, with a hematologic malignancy for which allogeneic transplant is considered an appropriate treatment and the patient is not eligible for a conventional myeloablative transplant because of organ dysfunction AND/OR * Any patient, regardless of age, who has relapsed following prior autologous or allogeneic transplant for a hematologic malignancy AND/OR * Any patient, regardless of age, with one of the following hematological malignancies: 1. Multiple myeloma 1. refractory to or failure following conventional chemotherapy such as VAD (Vincristine, Adriamycin and Dexamethasone), pulse decadron, or alkylating agents, or 2. chromosomal abnormality associated with poor prognosis by cytogenetics or FISH probe. 2. Chronic lymphocytic leukemia patients, Rai stage 3 or 4 and relapsed following/refractory to alkylating agents or nucleoside analog therapy 3. Low grade lymphoma (small lymphocytic, follicular small cleaved cell, or follicular mixed small cleaved and large cell) that is either relapsed or refractory provided the disease is NOT rapidly progressive, NOT bulky, and no mass exceeds 5 cm in greatest dimension. To be eligible a patient MUST meet all of the following criteria * In addition to the above criteria ALL patients must meet the following minimum organ function: 1. Cardiac: Ejection fraction at least 30%. 2. Renal: Adequate renal function as defined by creatinine \< 2.0mg OR creatinine clearance \>40 mg/min by 24-hour urine collection or GFR (Glomerular Filtration Rate. (Gender and age-adjusted creatinine clearance \>40ml/min by Gault-Cockroft 55 is acceptable for adults: (140 - age) x weight/72 x Scr \[x 0.85 if female\]). 3. Pulmonary: FEV1 and FVC \>60%. 4. Hepatic: Total bilirubin \<2.0 and AST (Aspartate Aminotransferase)/ALT (Alanine Transaminase) \< 3X institutional normal for age. 5. Performance (adults): Karnofsky score must be at least 60; for pts. under 16, Lansky score must be at least 60. * Availability of a 5/6 or 6/6 HLA A, B, and DR identical relative who is willing and able to donate allogeneic stem cells. Serological, low resolution or mid resolution molecular typing will determine the degree of match for HLA (Human Leukocyte Antigen) class I regardless of high resolution DNA typing results. High resolution typing will be used to determine the degree of match for HLA-DR. * No untreated or uncontrolled invasive infections. Patients still under therapy for presumed or proven infection are eligible provided there is clear evidence (radiologic and/or culture) that the infection is well controlled. Patients under treatment for infection will be enrolled only after clearance from the Principal Investigator. * Not pregnant Patient Exclusion Criteria: * acute leukemia * HIV positive patients not eligible * Any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient * Pregnant Donor Inclusion Criteria: * 5/6 or 6/6 HLA match for HLA-A, B, and DR * Age 3-70 years, good general health * No contraindication to G-CSF (Granulocyte Colony-Stimulating Factor)stimulation * No contraindication to leukapheresis of peripheral blood stem cells * Good general health Donor Exclusion Criteria: * HIV positive or history of HIV risk factors * Presence of other diseases transmissible by blood that pose unacceptable risk to the study subject. * Pregnant * Medical or psychological conditions that would make the donor unlikely to tolerate G-CSF - injections or leukapheresis
healthy Volunteers: false
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
intervention Names
Procedure: Reduced intensity conditioning
Procedure: Rapid immunosuppressive taper
Procedure: Prophylactic donor leukocyte infusions
label
Immunosuppression Taper
type
EXPERIMENTAL

interventions

arm Group Labels
Immunosuppression Taper
description
Busulfan and Fludarabine regimen
name
Reduced intensity conditioning
type
PROCEDURE
arm Group Labels
Immunosuppression Taper
description
Taper of Tacrolimus, Methotrexate and Mycophenolate Mofetil
name
Rapid immunosuppressive taper
type
PROCEDURE
arm Group Labels
Immunosuppression Taper
description
If the patient has GVHD overall grade 0-1 or skin grade 1 on day +100, then 5 x 107 CD3+ cells/kg recipient weight are given.
name
Prophylactic donor leukocyte infusions
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 54
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
The primary objective of this study was to establish the rate of acute GVHD following prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies. Glucksberg staging was used for organ grading of GVHD. Clinical GVHD was assessed as follows: Grade 0: No stage 1-4 of any organ Grade 1: Stage 1-2 rash and no liver or gut involvement Grade 2: Stage 3 rash, or Stage 1 liver involvement, or Stage 1 GI Grade 3: Stage 0-3 skin with Stage 2-3 liver, or Stage 2-4 GI Grade 4: Stage 4 skin rash, or Stage 4 liver involvement
measure
Percentage of Participants With Acute Graft Versus Host Disease (GVHD) Grades 2-4
time Frame
100 days
description
The second primary objective was to determine the percentage of participants with progression free survival following prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies. We define disease progression as disease recurrence within 180 days of transplant.
measure
Percentage of Participants With Progression Free Survival
time Frame
two years

secondary Outcomes

description
To estimate the overall survival of patients progression following prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies.
measure
Percentage of Patients Alive at 2 Years
time Frame
2 Years

Full study description

brief Summary: The purpose of this study is to determine whether a reduced intensity conditioning regimen for stem cell transplant with donor cells will allow the donor cells to be effective without causing health problems.
detailed Description: In this research study patients will receive dosages of chemotherapy that are lower than the usual dosages. The study will determine whether a shorter duration of immunosuppression will permit the donor cells to be effective against the cancer without causing more severe GVHD (Graft Versus Host Disease). Also to be determined is whether the patient's cancer can be prevented from relapsing after blood stem cell transplant by using prophylactic treatment, giving a donor leukocyte infusion BEFORE a relapse happens. In this research study samples of blood and bone marrow will be analyzed. These samples will be examined to study the cellular production of inflammatory cytokine levels in attempt to be able to predict which patients will have complications like GVHD or relapse.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-49504b52db2b1bc4dddd
requested nct id
NCT00143845
primary nct id
NCT00143845
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
7a5cb9aa985a293e6869014b6e0342cce295aac101b6359f45644a851c4b29d5
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-49504b52db2b1bc4dddd
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00143845
occurrences
context exact
NCT00143845
end
11
exact text
NCT00143845
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/211/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
c71603f1c2c8c5bd87e279374bd381c23f141ecb3322ce6476c5167aad1ca72f
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