NCT00051311 · OUTCOME

Number of Recipients With a Response to Reduced-intensity Stem Cell Transplantation (RIST)

Modified Stem Cell Transplant Procedure to Treat Patients With Blood and Immune System Cancers · Source last updated 2021-09-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: At least 100 days after post reduced-intensity stem cell transplantation (RIST).

What was measured

Complete remission (CR) is complete disappearance of all detectable signs and symptoms of lymphoma for a period of at least one month. Complete remission unconfirmed (CRu) is a residual lymph node mass \> 1.5 cm in greatest transverse diameter will be considered CRu if it has regressed by more than 75% in the SPD, does not change over at least one month, is negative by PET or gallium, and is negative on any biopsies obtained (biopsy not required). Progressive disease (PD) is a 25% or greater increase in SPD of all measured lesions compared to the smallest previous measurements, or appearance of any new lesion(s).

Groups in this outcome

Recipient

Recipients will receive induction chemotherapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. (one cycle is 5 days on drug therapy followed by a 16 day rest period). Prior to the transplant procedure, recipients will receive conditioning therapy followed by the infusion of donor stem cells. Methotrexate: Recipients will receive 4 doses of methotrexate by vein after the transplant to help prevent graft-versus-host disease (GVHD). Cyclosporine: Recipients will receive cyclosporine by vein or by mouth for about 6 months after the transplant to help prevent graft-versus-host disease (GVHD).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Recipient	31

Reported measurements

Complete Remission or Complete Remission Unconfirmed

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Recipient	15	Not reported	Not reported	Not reported	Not reported

Progressive Disease

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Recipient	16	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
15
title
Complete Remission or Complete Remission Unconfirmed
categories
measurements
group Id
OG000
value
16
title
Progressive Disease

denoms

counts
group Id
OG000
value
31
units
Participants

description

groups

description
Recipients will receive induction chemotherapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. (one cycle is 5 days on drug therapy followed by a 16 day rest period). Prior to the transplant procedure, recipients will receive conditioning therapy followed by the infusion of donor stem cells. Methotrexate: Recipients will receive 4 doses of methotrexate by vein after the transplant to help prevent graft-versus-host disease (GVHD). Cyclosporine: Recipients will receive cyclosporine by vein or by mouth for about 6 months after the transplant to help prevent graft-versus-host disease (GVHD).
id
OG000
title
Recipient

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

At least 100 days after post reduced-intensity stem cell transplantation (RIST).

title

Number of Recipients With a Response to Reduced-intensity Stem Cell Transplantation (RIST)

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice