Phase II Study of Folotyn With Leucovorin to Prevent/Reduce Mucositis in Patients With Hematological Malignancies
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02106650 |
Recruitment Status :
Completed
First Posted : April 8, 2014
Last Update Posted : November 20, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Relapsed Peripheral T-Cell Lymphoma Refractory Peripheral T-Cell Lymphoma | Drug: Folotyn and Leucovorin Drug: Folic Acid Drug: Vitamin B12 | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | 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 |
Actual Study Start Date : | July 2014 |
Actual Primary Completion Date : | October 2018 |
Actual Study Completion Date : | June 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Folotyn and Leucovorin
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. |
Drug: Folotyn and Leucovorin
Other Name: Pralatrexate (Folotyn) Drug: Folic Acid 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. Drug: Vitamin B12 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. |
- Grade 2 Oral Mucositis Prevention [ Time Frame: 15 weeks ]To evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis.
- Grade 3 Oral Mucositis Prevention [ Time Frame: 15 weeks ]To evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 3 or higher oral mucositis.
- Grade 2 Oral Mucositis Duration of first occurrence [ Time Frame: 15 weeks ]To evaluate the time to first occurrence of Folotyn-related Grade 2 or higher oral mucositis.
- Grade 2 Oral Mucositis Duration [ Time Frame: 15 weeks ]To evaluate the duration of Folotyn-related Grade 2 or higher oral mucositis.
- Effectiveness of Leucovorin in Folotyn dose modification [ Time Frame: 15 weeks ]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.
- Objective Response Rate [ Time Frame: 17 weeks ]To evaluate objective response rate (ORR) of Folotyn in patients with relapsed or refractory (R/R) PTCL.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient is diagnosed with hematological malignancies including PTCL and CTCL and are eligible for treatment with a dose of 30 mg/m^2
- Patient is at least 18 years of age
- Patient has been informed of the investigational nature of this study and has given written Informed Consent and is able to adhere to dosing and visit schedules and meet all study requirements
- Patient has recovered from the toxic effects of prior therapy, and is at least 30 days from the most recent cytotoxic therapy, prior to enrollment
-
Patient has adequate hematologic, hepatic, and renal function as defined by:
- ANC ≥1000/µL
- Platelet count ≥100,000/µL
- Total bilirubin ≤1.5 mg/dL
- Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT), and gamma-glutamyltransferase (GGT) ≤2.5 xupper limit of normal (ULN) (AST/ALT/GGT ≤5 xULN if documented hepatic involvement with lymphoma)
- Creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥50 mL/min
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Females of childbearing potential are to agree to practice a medically acceptable contraceptive regimen (including a barrier method) from study treatment initiation until at least 30 days after the last administration of Folotyn or leucovorin, whichever is last, and are to have a negative urine beta human chorionic gonadotropin (β-HCG) pregnancy test within 14 days prior to the first day of study treatment. Females who are postmenopausal for at least 1 year (defined as >12 months since last menses) or are surgically sterilized do not require this test
- Male patients are to agree to use a barrier method of contraception from study treatment initiation until at least 90 days after the last administration of Folotyn
Exclusion Criteria:
- Patient has congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification
- Patient has uncontrolled hypertension
- Patient has known, uncontrolled human immunodeficiency virus (HIV)-positive diagnosis
- Patient has symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Patients who received prophylactic CNS treatment are eligible
- Patient has an active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
- Patient has had major surgery within 14 days prior to enrollment
- Patient has used any investigational drugs, biologics, or devices within 14 days prior to study treatment or plans to use any of these during the course of the study
- Patient has had previous exposure to Folotyn within 6 months of study enrollment
- Patient is pregnant or breast-feeding

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106650
United States, California | |
City of Hope | |
Duarte, California, United States, 91010 | |
United States, Kansas | |
Cancer Center of Kansas | |
Wichita, Kansas, United States, 67214 | |
United States, Washington | |
Seattle Cancer Care Alliance | |
Seattle, Washington, United States, 98109 |
Study Director: | Wasim Khan, MD | Acrotech Biopharma LLC |
Responsible Party: | Acrotech Biopharma LLC |
ClinicalTrials.gov Identifier: | NCT02106650 |
Other Study ID Numbers: |
SPI-FOL-14-201 |
First Posted: | April 8, 2014 Key Record Dates |
Last Update Posted: | November 20, 2019 |
Last Verified: | November 2019 |
Relapsed PTCL Refractory PTCL |
Lymphoma Lymphoma, T-Cell Hematologic Neoplasms Lymphoma, T-Cell, Peripheral Mucositis Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Mouth Diseases Stomatognathic Diseases Neoplasms by Site Hematologic Diseases Leucovorin Folic Acid Vitamin B 12 Hydroxocobalamin Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Antidotes Protective Agents |