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Alkylating agents

Busulfan for Non-Hodgkin's Lymphoma

Phase 2
Waitlist Available
Led By Abraham Kanate, MD
Research Sponsored by West Virginia University
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 year
Awards & highlights

Study Summary

This trial is testing a new, less toxic way to prepare patients for a stem cell transplant, which may help people with Hodgkin's or non-Hodgkin's lymphoma.

Eligible Conditions
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Lymphoma

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of 1 Year Overall Survival (OS)
Percentage of 1-year Progression Free Survival (PFS)
Percentage of 2 Year Overall Survival (OS)
+1 more
Secondary outcome measures
Non-Relapse Mortality (NRM) Following RTC Transplantation at 1 Year.
Non-Relapse Mortality (NRM) Following RTC Transplantation at 2 Years.
Rates of Acute and Chronic Graft Versus Host Disease (GVHD).
+2 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: Allogeneic hematopoietic progenitor cell transplantExperimental Treatment2 Interventions
Intravenous busulfex 130mg/m2 on days -6 to -3 before transplant
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Busulfan
FDA approved
Fludarabine
FDA approved

Find a Location

Who is running the clinical trial?

West Virginia UniversityLead Sponsor
175 Previous Clinical Trials
56,284 Total Patients Enrolled
Abraham Kanate, MDPrincipal InvestigatorWest Virginia University

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
Once Daily Targeted Intravenous (IV) Busulfex as Part of Reduced-toxicity Conditioning for Patients With Refractory Lymphomas Undergoing Allogeneic Transplantation
2010. "Once Daily Targeted Intravenous (IV) Busulfex as Part of Reduced-toxicity Conditioning for Patients With Refractory Lymphomas Undergoing Allogeneic Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01203020.
~2 spots leftby Apr 2025
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