Trial · NCT01041508

Clofarabine and Low Dose Total Body Irradiation as a Preparative Regimen for Stem Cell Transplant in Leukemia.

NCT01041508, Phase 1, Completed, Therapeutic Advances in Childhood Leukemia Consortium; results first posted 2024-02-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clofarabine and Low Dose Total Body Irradiation as a Preparative Regimen for Stem Cell Transplant in Leukemia. Trials, record NCT01041508. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01041508

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Clofarabine and Low Dose Total Body Irradiation as a Preparative Regimen for Stem Cell Transplant in Leukemia.
NCT number: NCT01041508
Status: Completed
Phases: Phase 1
Enrollment: 18 participants, actual
Lead sponsor: Therapeutic Advances in Childhood Leukemia Consortium
Conditions: Leukemia Lymphoblastic, Acute, Acute Myeloid Leukemia, Neoplasm Recurrent
Interventions: Clofarabine, Total Body Irradiation, Stem Cell Transplantation, Cyclosporine, Mycophenolate Mofetil
First posted: 2009-12-31
Last updated: 2024-02-01
Results first posted: 2024-02-01

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Feasible Dose of Clofarabine	Day +100	The primary objective of the study is to determine the maximum feasible dose (MFD) of Clofarabine that can be given in combination with 2Gy total body irradiation as a non-myeloablative preparative regimen for allogeneic stem cell transplantation in pediatric patients with relapsed leukemia. The MFD is defined as the highest clofarabine dose associated with both an acceptably low toxicity and low non-engraftment (NE) rate. NE is defined as \< 5% donor T cells at any time point during serial monitoring. Monitoring during the evaluation period is required Day +30, +60 and +100.
Secondary	Days of Engraftment in Both Matched Related Donor (MRD) and Matched Unrelated Donor (MUD)	Days +30, 60, 100, 180	Donor engraftment will be assessed by serial monitoring of T-cell (CD3) and myeloid (CD33) chimerism at day +30, 60, 100, 180 and 1 year at the local institution using PCR based VNTR/STR amplification techniques. Neutrophil engraftment is defined as first day of an ANC ≥500/μL on 3 consecutive measurements.
Secondary	Transplant Related Mortality (TRM) at Day +100	Day 100	TRM is defined as any mortality within the first 100 days post stem cell infusion associated with regimen related toxicity, infection, or GVHD.
Secondary	Days to Platelet Recovery	Days +30, 60, 100, 180	Platelet recovery is defined as the first day of 3 consecutive measurements of platelets ≥20,000/μL after at least 7 days without transfusion support.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Feasible Dose of Clofarabine	Day +100	This analysis was performed for the entire study population. Cohorts were not separately analyzed for the maximum feasible dose of clofarabine.	mg/m^2	NUMBER
SECONDARY	Days of Engraftment in Both Matched Related Donor (MRD) and Matched Unrelated Donor (MUD)	Days +30, 60, 100, 180		Days	MEDIAN
SECONDARY	Transplant Related Mortality (TRM) at Day +100	Day 100		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Days to Platelet Recovery	Days +30, 60, 100, 180		Days	MEAN
POST_HOC	Number of Participants With Acute GVHD ≥ Grade 2	Within 100 Days Post-SCT (Stem Cell Transplant)		Participants	COUNT_OF_PARTICIPANTS
POST_HOC	CD3 Donor Chimerism at Day 30 (Full Donor)	Day 30		Participants	COUNT_OF_PARTICIPANTS
POST_HOC	CD3 Donor Chimerism at Day 30 (Mixed Chimerism)	Day 30		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group25

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Maximum Feasible Dose of Clofarabine	Entire Study Population	52		mg/m^2
Days of Engraftment in Both Matched Related Donor (MRD) and Matched Unrelated Donor (MUD)	Cohort A- Related Donor- Dose Level 1	20	Full Range 17 to 22	Days
Days of Engraftment in Both Matched Related Donor (MRD) and Matched Unrelated Donor (MUD)	Cohort B- Related Donor- Dose Level 2	19.5	Full Range 14 to 25	Days
Days of Engraftment in Both Matched Related Donor (MRD) and Matched Unrelated Donor (MUD)	Cohort C- Unrelated Donor- Dose Level 1	19	Full Range 19 to 20	Days
Days of Engraftment in Both Matched Related Donor (MRD) and Matched Unrelated Donor (MUD)	Cohort D- Unrelated Donor- Dose Level 2	15.5	Full Range 9 to 19	Days
Transplant Related Mortality (TRM) at Day +100	Cohort A- Related Donor- Dose Level 1	0		Participants
Transplant Related Mortality (TRM) at Day +100	Cohort B- Related Donor- Dose Level 2	0		Participants
Transplant Related Mortality (TRM) at Day +100	Cohort C- Unrelated Donor- Dose Level 1	0		Participants
Transplant Related Mortality (TRM) at Day +100	Cohort D- Unrelated Donor- Dose Level 2	0		Participants
Days to Platelet Recovery	Cohort A- Related Donor- Dose Level 1	10	Full Range 7 to 17	Days

1 to 10 of 25Source ClinicalTrials.gov

See all 25 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Cohort A - Related Donor- Dose Level 1	3
Overall Study	STARTED	Cohort B - Related Donor- Dose Level 2	6
Overall Study	STARTED	Cohort C- Unrelated Donor- Dose Level 1	3
Overall Study	STARTED	Cohort D- Unrelated Donors- Dose Level 2	6
Overall Study	COMPLETED	Cohort A - Related Donor- Dose Level 1	3
Overall Study	COMPLETED	Cohort B - Related Donor- Dose Level 2	6
Overall Study	COMPLETED	Cohort C- Unrelated Donor- Dose Level 1	3
Overall Study	COMPLETED	Cohort D- Unrelated Donors- Dose Level 2	6
Overall Study	NOT COMPLETED	Cohort A - Related Donor- Dose Level 1	0
Overall Study	NOT COMPLETED	Cohort B - Related Donor- Dose Level 2	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events70

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain NOS	Gastrointestinal disorders	40 mg/m2 Dose	0	6
other	Abdominal pain NOS	Gastrointestinal disorders	52 mg/m2 Dose	1	12
other	Adrenal insufficiency NOS	Endocrine disorders	40 mg/m2 Dose	0	6
other	Adrenal insufficiency NOS	Endocrine disorders	52 mg/m2 Dose	1	12
other	Alanine aminotransferase increased	Investigations	40 mg/m2 Dose	6	6
other	Alanine aminotransferase increased	Investigations	52 mg/m2 Dose	4	12
other	Anorexia	Metabolism and nutrition disorders	40 mg/m2 Dose	2	6
other	Anorexia	Metabolism and nutrition disorders	52 mg/m2 Dose	5	12
other	Aspartate aminotransferase increased	Investigations	40 mg/m2 Dose	5	6
other	Aspartate aminotransferase increased	Investigations	52 mg/m2 Dose	3	12

1 to 10 of 70Source ClinicalTrials.gov

See all 70 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	40 mg/m2 Dose	1	6
Total, all-cause mortality	52 mg/m2 Dose	5	12
Total, other adverse events	40 mg/m2 Dose	6	6
Total, other adverse events	52 mg/m2 Dose	10	12
Total, serious adverse events	40 mg/m2 Dose	1	6
Total, serious adverse events	52 mg/m2 Dose	0	12

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28396162	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
40 mg/m2 Dose vs 52 mg/m2 Dose: deaths from any cause	Trial comparisons
40 mg/m2 Dose vs 52 mg/m2 Dose: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01041508

GET https://conductscience.org/api/trials/v1/NCT01041508/results?page=2

API reference For AI assistants