A Phase 2 interventional study of Palifermin and Panobinostat in Lymphoma, sponsored by M.D. Anderson Cancer Center. Withdrawn. Open to participants aged 15 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-04-21.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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.
Busulfan Test Dose:
Participant will receive a test dose of busulfan by vein over about 60 minutes. Before and after participant receives this low-level test dose of busulfan, blood will be drawn several times to check how the level of busulfan in participant's blood changes over time. This is called pharmacokinetic (PK) testing. This information will be used to decide the next dose needed to reach the correct blood level that matches participant's body size. Participant will most likely receive this test dose as an outpatient during the week before participant is admitted to the hospital. If it cannot be given as an outpatient, participant will be admitted to the hospital on Day -11 (11 days before participant's stem cells are returned to participant's body) and the test dose will be given on Day -10.
Blood (about 1 teaspoon each time) will be drawn for PK testing about 11 times before participant's test dose of busulfan and 10 times over the 11 hours after the dose. The blood samples will be repeated again on the first day of high-dose busulfan treatment (Day -8). A temporary heparin lock line will be placed in participant's vein to lower the number of needle sticks needed for these draws.
If it is not possible for the PK tests to be performed for any reason, participant will receive the standard fixed dose of busulfan.
Study Drug Administration:
On Days -13 through -11 (the 3 days before participant is admitted to the hospital), participant will receive palifermin by vein over about 30 seconds each day to help decrease the risk of side effects in the mouth and throat.
On Day -9 through Day -2, participant will take panobinostat by mouth, with food. The study staff will tell participant how many tablets to take. Participant will receive dexamethasone by vein over about 3-5 minutes 2 times each day.
On Day -9, if participant has a type of B-cell cancer, participant will receive rituximab (a treatment used for certain lymphomas) by vein over about 3-6 hours as part of participant's standard care. The study doctor will tell participant if participant will receive rituximab.
On Day -8, participant will receive gemcitabine by vein over 4½ hours.
On Days -8, -7, -6, and -5, participant will receive busulfan by vein over about 60 minutes.
On Day -3, participant will receive gemcitabine by vein over 4½ hours and then melphalan by vein over 30 minutes.
On Day -2, participant will receive melphalan by vein over 30 minutes.
On Day -1, participant will rest (participant will not receive chemotherapy).
On Day 0, participant will receive participant's stem cells by vein over about 30-60 minutes.
Participant will receive 3 more doses of palifermin by vein, over 15-30 seconds each time, on Days 0, +1, and +2.
As part of standard care, participant will receive G-CSF (filgrastim) as an injection just under participant's skin 1 time each day starting on Day +5 until participant's blood cell levels return to normal. The study doctor will discuss this with participant, including how filgrastim is given and its risks.
Length of Study:
As part of standard care, participant will remain in the hospital for about 3-4 weeks after the transplant. After participant is released from the hospital, participant will continue as an outpatient. Participant will need to stay in the Houston area to be checked for infections and side effects.
Participant will be taken off study about 100 days after the transplant. Participant may be taken off study earlier if the disease gets worse, if intolerable side effects occur, or if participant is unable to follow study directions.
Study Tests:
About 100 days after the transplant:
This is an investigational study. Panobinostat and melphalan are FDA approved and commercially available for the treatment of multiple myeloma (MM). Busulfan is FDA approved and commercially available for the treatment of leukemia. Gemcitabine is FDA approved and commercially available for the treatment of lymphoma, breast cancer, and lung cancer. Rituximab is FDA approved and commercially available for the treatment of non-Hodgkin's lymphoma.
The use of these study drugs in combination is investigational. The study doctor can explain how the study drugs are designed to work.
Up to 75 participants will take part in this study. All will be enrolled at MD Anderson.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
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Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
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Exclusion Criteria:
Palifermin on Days -13 to -11 and on Days 0, +1, and +2. Panobinostat daily from Day -9 to -2. Gemcitabine administered on Days -8 and -3. Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK. Melphalan on Days -3 and -2. Rituximab on Day -9 for participants with CD20+ tumors. Dexamethasone twice a day from Day -8 AM to Day -2 PM. Caphosol oral rinses 30 mL four times a day used from Day -8. Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8. Pyridoxine three times a day from Day -1. Stem cells administered by vein on Day 0. G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
Drug: Palifermin · Drug: Panobinostat · Drug: Gemcitabine · Drug: Busulfan · Drug: Melphalan · Drug: Rituximab · Drug: Dexamethasone · Drug: Caphosol · Drug: Glutamine · Other: Oral Cryotherapy (ice chips) · Drug: Pyridoxine · Biological: Stem Cell Infusion · Drug: G-CSF
Palifermin on Days -13 to -11 and on Days 0, +1, and +2. Panobinostat daily from Day -9 to -2. Gemcitabine administered on Days -8 and -3. Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK. Melphalan on Days -3 and -2. Rituximab on Day -9 for participants with CD20+ tumors. Dexamethasone twice a day from Day -8 AM to Day -2 PM. Caphosol oral rinses 30 mL four times a day used from Day -8. Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8. Pyridoxine three times a day from Day -1. Stem cells administered by vein on Day 0. G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
Drug: Palifermin · Drug: Panobinostat · Drug: Gemcitabine · Drug: Busulfan · Drug: Melphalan · Drug: Rituximab · Drug: Dexamethasone · Drug: Caphosol · Drug: Glutamine · Other: Oral Cryotherapy (ice chips) · Drug: Pyridoxine · Biological: Stem Cell Infusion · Drug: G-CSF
Palifermin on Days -13 to -11 and on Days 0, +1, and +2. Panobinostat daily from Day -9 to -2. Gemcitabine administered on Days -8 and -3. Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK. Melphalan on Days -3 and -2. Rituximab on Day -9 for participants with CD20+ tumors. Dexamethasone twice a day from Day -8 AM to Day -2 PM. Caphosol oral rinses 30 mL four times a day used from Day -8. Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8. Pyridoxine three times a day from Day -1. Stem cells administered by vein on Day 0. G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
Drug: Palifermin · Drug: Panobinostat · Drug: Gemcitabine · Drug: Busulfan · Drug: Melphalan · Drug: Rituximab · Drug: Dexamethasone · Drug: Caphosol · Drug: Glutamine · Other: Oral Cryotherapy (ice chips) · Drug: Pyridoxine · Biological: Stem Cell Infusion · Drug: G-CSF
Palifermin, per standard of care, on Days -13 to -11 and on Days 0, +1, and +2.
Also known as: Kepivance
20 mg by mouth daily from Day -9 to -2.
Also known as: LBH589B
Gemcitabine administered as a loading dose of 75 mg/m2 by vein followed by prolonged infusion over 4.5 hours of 2,700 mg/m2 (total daily dose 2,775 mg/m2) on Days -8 and -3.
Also known as: Gemcitabine Hydrochloride, Gemzar
Busulfan "test dose" administered on Day -10. Test dose of 32 mg/m2 based on actual body weight administrated over 60 minutes. Busulfan pharmacokinetics performed with the test dose and the first dose on Day-8. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Also known as: Busulfex, Myleran
60 mg/m2 by vein on Days -3 and -2.
Also known as: Alkeran
375 mg/m2 by vein on Day -9 for patients with CD20+ tumors.
Also known as: Rituxan
8 mg by vein twice a day from Day -8 AM to Day -2 PM.
Also known as: Decadron
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral Glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Also known as: Enterex, Glutapak-10, NutreStore, Resource, GlutaSolve, Sympt-X G.I., Sympt-X
Oral cryotherapy (ice chips) from 30 minutes before until 2 hours after each Melphalan infusion.
100 mg by vein or mouth three times a day from Day -1.
Stem cells administered by vein on Day 0.
Also known as: Stem Cell Transplant
G-CSF administered as an injection just under the skin, per standard of care ,1 time each day starting on Day +5 until blood cell levels return to normal.
Also known as: Filgrastim, Neupogen
Event-Free Survival (EFS) in Participants with Diffuse Large B-Cell Lymphoma
EFS estimated by using the method of Kaplan and Meier.
Time frame: 2 years
Event-Free Survival (EFS) in Participants with Hodgkin's Lymphoma
EFS estimated by using the method of Kaplan and Meier.
Time frame: 2 years
Event-Free Survival (EFS) in Participants with T-Cell Lymphoma
EFS estimated by using the method of Kaplan and Meier.
Time frame: 2 years
Treatment-Related Mortality (TRM)
(TRM) monitored by using the method of Thall, Simon, and Estey.
Time frame: 100 days
Overall Survival (OS)
OS estimated by using the method of Kaplan and Meier.
Time frame: 100 days
No study locations are listed for this record.
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M.D. Anderson Cancer Center