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Anti-metabolites

Clofarabine for Diffuse Large B-Cell Lymphoma

Phase 1 & 2
Waitlist Available
Led By Jeremy Abramson, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 and 2 years
Awards & highlights

Study Summary

This trial is studying how well oral clofarabine works in treating patients with non-Hodgkin lymphoma that has come back.

Eligible Conditions
  • Diffuse Large B-Cell Lymphoma
  • Peripheral T-Cell Lymphoma
  • Mantle Cell Lymphoma
  • B-Cell Lymphoma
  • Lymphoplasmacytic Lymphoma
  • Follicular Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Marginal Zone Lymphoma
  • Lymphoma
  • T-Cell Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 and 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
All Phase I-II Participants: Overall Response Rate (ORR)
Phase I Participants Only: Overall Response Rate (ORR)
Secondary outcome measures
All Phase I Participants: Overall Survival (OS)
All Phase I-II Participants: Overall Survival (OS)
All Phase I-II Participants: Progression-free Survival (PFS)
+5 more

Side effects data

From 2020 Phase 3 trial • 256 Patients • NCT01471444
95%
Nausea
95%
Mucositis
82%
Elevated transminitis
79%
Infections
55%
Skin GvHD
50%
ATG induced fevers
45%
Fluid overload
32%
Diarrhea
32%
Neutropenic fevers
29%
Hypertension
27%
Upper GI GvHD
22%
Renal insufficiency
19%
Liver GvHD
18%
Chronic ocular GvHD
15%
ATG induced skin rash
15%
BK virus associated hemorrhagic cystitis
15%
Chronic oral GvHD
14%
GI GvHD
12%
Pneumonitis
11%
Rash
8%
Headaches
8%
Palmar-plantar erythrodysesthesia
7%
Chronic lung GvGHD
3%
ABO incompatibility
3%
Dysrhythmia
3%
Viral Infections
2%
Poor graft function
2%
Cardiomyopathy
2%
Allergic reaction to ATG
2%
Fungal Infections
2%
Ascites
2%
Hemorrhagic cystits
2%
Diffused alveolar hemorrhage
2%
Thrombocytopenia
2%
Skin GVHD
2%
Bacterial Infections
1%
PRES
1%
Hemochromatosis
1%
Transcient secondary graft failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (Flu+Bu)
Arm B (Flu+Clo+Bu)

Trial Design

1Treatment groups
Experimental Treatment
Group I: ClofarabineExperimental Treatment1 Intervention
Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clofarabine
FDA approved

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalOTHER
1,612 Previous Clinical Trials
11,470,525 Total Patients Enrolled
Genzyme, a Sanofi CompanyIndustry Sponsor
524 Previous Clinical Trials
85,580 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,931 Previous Clinical Trials
13,198,395 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma
Jeremy Abramson, MD 2008. "Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00644189.
~3 spots leftby Apr 2025
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