Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Digestive System Diseases

Mouth and Tooth Diseases

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Hematologic Neoplasms

Mucositis

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Hematologic Diseases

Lymphosarcoma

Peripheral T-cell Lymphoma

Micronutrients

All Drugs and Chemicals

Hematinics

Vitamins

Leucovorin

Folic Acid

Vitamin B Complex

Vitamin B 12

Hydroxocobalamin

Trace Elements

Antidotes

Protective Agents

Folinic Acid

Methylcobalamin

Folate

Vitamin B9

Vitamin B12

Cobalamin

Cyanocobalamin

Folotyn will be administered by IV push at a dose of 30 mg/m2 once weekly for 6 weeks in each cycle, followed by 1 week of rest (no treatment).

Leucovorin (25 mg tablets) will be taken orally tid for 2 days for a total of six doses (150 mg cumulative weekly dose), beginning 24 hours after each dose of Folotyn is administered.

Folic acid and Vitamin B12 is given prior to initiation of Folotyn.

Folotyn and Leucovorin

Folic acid (1.0 mg PO QD) is to be initiated at least 10 days prior to Folotyn administration, or per the USPI for Folotyn.

Vitamin B12 (1 mg IM) is to be administered within 10 weeks prior to initiation of Folotyn and can be administered during Screening. Subsequent vitamin B12 injections may be given the same day as treatment with Folotyn and patients are to receive vitamin B12 every 8 to 10 weeks while treated with Folotyn.

Wasim Khan, MD

This study is to evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis.

This is a Phase 2, single-arm, open-label, multicenter study to determine the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis in patients with hematological malignancies including PTCL and CTCL.

Patients with hematological malignancies, including PTCL and CTCL, will be enrolled based on meeting all protocol eligibility criteria. The primary endpoint will be evaluated in the first 7-week treatment cycle. For patients who respond to study treatment, the Investigator can treat patients for a total of 6 cycles. Approximately 37 patients will be enrolled. Safety, as assessed by reported SAEs, will continue to be monitored during the optional treatment period. Efficacy will be followed to the extent that it is evaluated according to the Institution's standard of care. No formal analysis of efficacy will be made.

Phase II Study of Folotyn With Leucovorin to Prevent/Reduce Mucositis in Patients With Hematological Malignancies

A Phase 2, Single-Arm, Open-Label, Multicenter, Study of Folotyn® (Pralatrexate Injection) in Combination With Oral Leucovorin to Prevent or Reduce Mucositis in Patients With Hematological Malignancies Including PTCL and CTCL

To evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis.

To evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 3 or higher oral mucositis.

To evaluate the time to first occurrence of Folotyn-related Grade 2 or higher oral mucositis.

To evaluate the duration of Folotyn-related Grade 2 or higher oral mucositis.

To evaluate the effect of leucovorin on the number and proportion of patients whose subsequent dose of Folotyn is omitted, delayed, or reduced due to the onset of oral mucositis.

To evaluate objective response rate (ORR) of Folotyn in patients with relapsed or refractory (R/R) PTCL.

Axis Clinicals Limited

Acrotech Biopharma Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase II Study of Folotyn With Leucovorin to Prevent/Reduce Mucositis in Patients With Hematological Malignancies	NCT02106650	Relapsed Periph... Refractory Peri...	Folotyn and Leu... Folic Acid Vitamin B12	18 Years -	Acrotech Biopharma Inc.
Phase II Study of Folotyn With Leucovorin to Prevent/Reduce Mucositis in Patients With Hematological Malignancies	NCT02106650	Relapsed Periph... Refractory Peri...	Folotyn and Leu... Folic Acid Vitamin B12	18 Years -	Acrotech Biopharma Inc.

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