Study: NCT02961816

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Palifermin
Description: Palifermin, per standard of care, on Days -13 to -11 and on Days 0, +1, and +2.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Palifermin
Description: Palifermin, per standard of care, on Days -13 to -11 and on Days 0, +1, and +2.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Palifermin
Description: Palifermin, per standard of care, on Days -13 to -11 and on Days 0, +1, and +2.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Panobinostat
Description: 20 mg by mouth daily from Day -9 to -2.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Panobinostat
Description: 20 mg by mouth daily from Day -9 to -2.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Panobinostat
Description: 20 mg by mouth daily from Day -9 to -2.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Busulfan
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Busulfan
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Busulfan
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Melphalan
Description: 60 mg/m2 by vein on Days -3 and -2.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Melphalan
Description: 60 mg/m2 by vein on Days -3 and -2.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Melphalan
Description: 60 mg/m2 by vein on Days -3 and -2.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: 375 mg/m2 by vein on Day -9 for patients with CD20+ tumors.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: 375 mg/m2 by vein on Day -9 for patients with CD20+ tumors.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: 375 mg/m2 by vein on Day -9 for patients with CD20+ tumors.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: 8 mg by vein twice a day from Day -8 AM to Day -2 PM.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: 8 mg by vein twice a day from Day -8 AM to Day -2 PM.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: 8 mg by vein twice a day from Day -8 AM to Day -2 PM.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Caphosol
Description: Caphosol oral rinses 30 mL four times a day used from Day -8.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Caphosol
Description: Caphosol oral rinses 30 mL four times a day used from Day -8.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Caphosol
Description: Caphosol oral rinses 30 mL four times a day used from Day -8.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Glutamine
Description: Oral Glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Glutamine
Description: Oral Glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Glutamine
Description: Oral Glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Oral Cryotherapy (ice chips)
Description: Oral cryotherapy (ice chips) from 30 minutes before until 2 hours after each Melphalan infusion.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Oral Cryotherapy (ice chips)
Description: Oral cryotherapy (ice chips) from 30 minutes before until 2 hours after each Melphalan infusion.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Oral Cryotherapy (ice chips)
Description: Oral cryotherapy (ice chips) from 30 minutes before until 2 hours after each Melphalan infusion.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pyridoxine
Description: 100 mg by vein or mouth three times a day from Day -1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pyridoxine
Description: 100 mg by vein or mouth three times a day from Day -1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pyridoxine
Description: 100 mg by vein or mouth three times a day from Day -1.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Stem Cell Infusion
Description: Stem cells administered by vein on Day 0.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Stem Cell Infusion
Description: Stem cells administered by vein on Day 0.