Overview

Panobinostat Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant for Patients With Refractory/Relapsed Lymphoma

Status:
Withdrawn
Trial end date:
2021-06-01
Target enrollment:
0
Participant gender:
All
Summary
The goal of this clinical research study is to learn about the safety and effectiveness of the combination of panobinostat, gemcitabine, busulfan, and melphalan, either with or without rituximab, in patients who have non-Hodgkin's or Hodgkin's lymphoma and are receiving a stem cell transplant.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
BB 1101
Busulfan
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Gemcitabine
Lenograstim
Melphalan
Panobinostat
Pyridoxal
Pyridoxine
Rituximab
Vitamin B 6
Criteria
Inclusion Criteria:

1. Age 15-65

2. Patients with: DLBCL with one of the following: 1. Primary refractory (no CR to 1st
line); 2. High-risk relapse (CR1 <6 months, secondary IPI >1 or high LDH); or, 3.
Refractory relapse: No response (SD or PD) to >/= 1 line of salvage.

3. Hodgkin's with one of the following: 1. Primary refractory (no CR to 1st line or PD
within 3 months); 2. High-risk relapse (CR1 <1 year, extranodal relapse or B
symptoms); or, 3. Refractory relapse: No response (SD or PD) to >/= 1 line of salvage.

4. T-NHL with one of the following: 1. Primary refractory ( within 6 months); or, 2. Nonresponsive (SD/PD) to >/= 1 line of salvage.

5. Adequate renal function, as defined by estimated serum creatinine clearance >/= 50
ml/min and/or serum creatinine
6. Adequate hepatic function (SGOT and/or serum glutamate pyruvate transaminase (SGPT)

7. Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced
vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO)
(corrected for Hgb) >/= 50%

8. Adequate cardiac function with left ventricular ejection fraction >/= 40%. No
uncontrolled arrhythmias or symptomatic cardiac disease

9. PS <2

10. Negative Beta human chorionic gonadotropin (HCG) in woman with child-bearing potential

Exclusion Criteria:

1. Grade >/= 3 non-hematologic toxicity from prior therapy that has not resolved to G1

2. Prior whole brain irradiation

3. Corrected QT interval (QTc) longer than 500 ms

4. Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA >/= 10,000
copies/mL, or >/= 2,000 IU/mL)

5. Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic
hepatitis C or positive hepatitis C serology

6. Active infection requiring parenteral antibiotics

7. HIV infection, unless receiving effective antiretroviral therapy with undetectable
viral load and normal cluster of differentiation 4 (CD4) counts

8. Radiation therapy in the month prior to enroll