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Immunotherapy

mycophenolate mofetil for Lymphoma

Phase 2
Waitlist Available
Led By Amir A Toor, MD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hodgkin lymphoma (HL)
Non-Hodgkin lymphoma (NHL)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization up to 2 years
Awards & highlights

Study Summary

This trial is testing two different doses of a drug to see which is better at preventing GVHD following a stem cell transplant. The trial will adapt based on T cell counts to see which dose is better at preventing relapse and GVHD.

Eligible Conditions
  • Lymphoma
  • Hodgkin's Lymphoma
  • Lymphocytic Leukemia
  • Multiple Myeloma
  • Acute Lymphoblastic Leukemia
  • Non-Hodgkin's Lymphoma
  • Leukemia
  • Acute Myeloid Leukemia
  • Chronic Lymphocytic Leukemia
  • Chronic Myelogenous Leukemia
  • Myelodysplastic Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Number of Patients With Relapse-free/Donor Lymphocyte Infusion(DLI)-Free Survival Rates Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort).
Secondary outcome measures
Determine the Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) With Diagnosis of Engraftment Loss.
Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) Diagnosed With Chronic Graft vs Host Disease (GVHD)
Differences Between Patients Randomized to MMF-30 (Control Cohort) and MMF-15 (Investigational Cohort) Diagnosed With Opportunistic Infections
+6 more

Side effects data

From 2009 Phase 3 trial • 252 Patients • NCT02005562
50%
Anaemia
31%
Kidney transplant rejection
25%
Urinary tract infection
22%
Oedema peripheral
18%
Leukopenia
18%
Hypertension
14%
Dyslipidaemia
11%
Cytomegalovirus infection
10%
Blood creatinine increased
10%
Neutropenia
10%
Diabetes mellitus
9%
Renal failure acute
8%
Graft dysfunction
7%
Hyperkalaemia
7%
Renal impairment
6%
Pyelonephritis
6%
Cough
6%
Dysuria
6%
Iron deficiency anaemia
6%
Pyrexia
6%
Bronchitis
6%
Proteinuria
5%
Gingival hypertrophy
5%
Diarrheoa
4%
Overweight
4%
Pyelonephritis acute
4%
Abdominal pain upper
3%
Diarrhoea
2%
Renal vein thrombosis
2%
Pneumocystis jiroveci pneumonia
2%
Ureteral necrosis
2%
Pulmonary embolism
2%
Agranulocytosis
2%
Febrile neutropenia
2%
Viral infection
2%
Lymphocele
2%
Herpes simplex
2%
Underweight
2%
Atrial fibrillation
2%
Sepsis
2%
Ischaemic stroke
2%
Phlebitis
2%
Blood creatinine abnormal
2%
Ureteric stenosis
2%
Gastroenteritis
1%
Back pain
1%
Therapeutic agent toxicity
1%
Cholangitis
1%
Bacterial pyelonephritis
1%
Rheumatoid arthritis
1%
Helicobacter gastritis
1%
Haematuria
1%
Lung disorder
1%
Muscle haemorrhage
1%
Oedema
1%
Inflammation
1%
Pneumonia
1%
Postrenal failure
1%
Orthopnoea
1%
Pyelonephritis chronic
1%
Rib fracture
1%
Acute pulmonary oedema
1%
Lymphoproliferative disorder
1%
Myocardial infarction
1%
Nodal arrhythmia
1%
Tachyarrhyrhmia
1%
Gastroenteritis viral
1%
Otitis externa
1%
Septic shock
1%
Staphylococcal sepsis
1%
Arteriovenous fistula site haemorrhage
1%
Arteriovenous fistula thrombosis
1%
Renal failure
1%
Renal haematoma
1%
Arteriosclerosis
1%
Arteritis
1%
Deep vein thrombosis
1%
Iliac artery stenosis
1%
Bronchitis acute
1%
Cardiac failure
1%
Hyperparathyroidism tertiary
1%
Gastrointestinal haemorrhage
1%
Asthenia
1%
Extravasation
1%
Hyperthermia
1%
Infection
1%
Klebsiella sepsis
1%
Renal cyst infection
1%
Epstein-Barr virus associated lymphoproliferative disorder
1%
Prostatic adenoma
1%
Migraine
1%
Graft thrombosis
1%
Post procedural haematuria
1%
Overdose
1%
Perirenal haematoma
1%
Arthritis
1%
Renal tubular necrosis
1%
Dyspnoea exertional
1%
Haemothorax
1%
Arterial thrombosis
1%
Post procedural haemorrhage
1%
Cytolytic hepatitis
1%
Pyelocaliectasis
1%
Dyspnoea
1%
Angina pectoris
1%
Anxiety disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mycophenolate Mofetil, Fixed Dose
Mycophenolate Mofetil, Adapted Dose

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (MMF-15, sargramostim)Experimental Treatment2 Interventions
Patients receive mycophenolate mofetil (MMF) PO or IV twice daily (BID) on days 0-15 and sargramostim SC from post-transplant day 4 until neutrophil engraftment.
Group II: Arm II (MMF-30, filgrastim)Active Control2 Interventions
Patients receive mycophenolate mofetil PO or IV (twice daily) BID on days 0-30 and filgrastim G-CSF from post-transplant day 4 until neutrophil engraftment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sargramostim
2008
Completed Phase 4
~710
mycophenolate mofetil
2000
Completed Phase 3
~1730

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
690 Previous Clinical Trials
22,884,878 Total Patients Enrolled
11 Trials studying Lymphoma
290 Patients Enrolled for Lymphoma
Massey Cancer CenterOTHER
9 Previous Clinical Trials
571 Total Patients Enrolled
2 Trials studying Lymphoma
20 Patients Enrolled for Lymphoma
Amir A Toor, MDPrincipal InvestigatorMassey Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can middle-aged adults join in this research project?

"This study is recruiting patients aged 18-74. Out of the 1002 trials for patients under 18 and 4616 trials for patients over 65, this is the only one that meets the age requirements."

Answered by AI

Mycophenolate mofetil is most often given to treat which condition?

"Mycophenolate mofetil is not only used to treat the steroid therapy, but also severe idiopathic neutropenia, acute lymphoblastic leukemia (all), and hemopoietic stem cell transplant."

Answered by AI

What is the most severe reaction that patients have had to mycophenolate mofetil?

"While there is some evidence of mycophenolate mofetil's safety, it is only from Phase 2 trials. None of the trials have yet found it to be an effective medication."

Answered by AI

Are there any available vacancies for individuals in this experiment?

"This trial is not currently looking for new participants. According to the posting date and most recent update, the study was active between 2015 and 2020. There are currently 4946 trials actively admitting patients with leukemia, lymphocytic and 317 studies for mycophenolate mofetil actively admitting patients."

Answered by AI
~3 spots leftby Mar 2025