Is NCT06029309 recruiting in Miami, FL?

Yes, NCT06029309 is currently recruiting participants at its Miami, FL location. This mantle cell lymphoma clinical trial is actively enrolling qualified participants.

How do I join the mantle cell lymphoma clinical trial in Miami?

To join this clinical trial in Miami, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Miami clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Mantle Cell Lymphoma Clinical Trial in Miami, FL

Who Can Participate

Inclusion Criteria

Men and women ≥ 18 years of age

Patients must have histologic confirmation of mantle cell lymphoma (MCL) defined by the World Health Organization (WHO) classification

Baseline PET/CT scans must demonstrate fluorodeoxyglucose (FDG) avid lesions compatible with CT defined anatomical tumor sites. Patients should have at least one measurable site of disease per Lugano classification

Patient should have indication according to primary investigator for treatment initiation

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Life expectancy of greater than 4 months.

Willingness to avoid pregnancy or fathering children during the study and for at least 90 days after the last dose of the study drug.

Patients must have normal organ and marrow function as defined below:

Absolute neutrophil count \>1,000/mm3 independent of growth factor support within 7 days of study entry (\>700/mm3 if lymphoma involvement of the bone marrow or spleen)

Platelets \>70,000/mm3 independent of transfusion support within 7 days of study entry (\>50,000/mm3 independent of transfusion support within 7 days of study entry if lymphoma involvement of the bone marrow or spleen)

Hemoglobin \>9 g/dL or \>8 g/dL in case of bone marrow involvement by lymphoma independent of transfusion support within 7 days of study entry.

Total bilirubin \< 1.5 x within normal institutional limits (unless known history of Gilbert's disease or up to 3 x upper limit of normal (ULN) if due to lymphoma involvement of liver)

Gamma-Glutamyl Transpeptidase (GGT)/Aspartate transaminase (AST, SGOT)/Alanine transaminase (ALT, SGPT) ≤ 2.5 x institutional upper limit of normal

Creatinine within normal institutional limits, or creatinine clearance ≥ 40 mL/min (as estimated by the Cockcroft-Gault equation) for patients with creatinine levels above institutional normal (creatinine clearance ≥ 30 mL/min as estimated by the Cockcroft-Gault equation if due to lymphoma). Inclusion Criteria, Phase 1 Only: 1\. Relapsed MCL patients with at least 1 but no more than 3 lines of therapy, regardless of previous Bruton Tyrosine Kinase (BTK) inhibitor exposure Inclusion Criteria, Phase 2 Only: 1\. Untreated symptomatic MCL deemed by the primary investigator not to be eligible for intensive combination immunochemotherapy.

Exclusion Criteria

, Phase 1 and 2:

Patients receiving any other investigational agents

Patients with known central nervous system involvement of lymphoma

Uncontrolled intercurrent illness such as: clinically significant active cardiovascular disease such as uncontrolled or symptomatic arrhythmia, uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) Class III-IV, history of myocardial infarction within 6 months of screening, stroke in last 6 months, liver cirrhosis, autoimmune disorder requiring immunosuppression or long-term corticosteroids (\>10 mg daily prednisone equivalent), or any other serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form

QT interval corrected with Fridericia's formula (QTcF) \> 450 msec or other significant ECG abnormalities including second-degree atrioventricular block Type II, or third-degree atrioventricular block

Prior or concurrent malignancies with exception of surgically cured carcinoma in situ (CIS) of the uterus, carcinoma of the skin without evidence of disease for ≥5 years

Concurrent malignancy requiring active therapy

Known seropositive and requiring anti-viral therapy for human immunodeficiency virus

Breastfeeding or pregnant women

Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody will need a polymerase chain reaction (PCR) below cutoff value prior to enrollment. (PCR positive patients will be excluded). Hepatitis C antibody positive patients are eligible if PCR is negative. Hepatitis B core antibody (+) patients without evidence of HBsAg or Hep B PCR (+) are eligible with appropriate Hepatitis B reactivation prophylaxis

Ongoing treatment with medications that are moderate or strong cytochrome P (CYP) 450, family 3, subfamily A (CYP3A) inhibitors, or strong CYP3A inducers that cannot be safely substituted. For patients with ongoing treatment with these medications that can be safely substituted, minimum washout period should be 7 days or five half-lives, whichever is shorter.

History of allogenic hematopoietic stem cell transplantation prior to enrollment

Active systemic infection (including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive test) or other Active infection including infections requiring oral or intravenous antimicrobial therapy.

Administration of live vaccine within 28 days prior to start of study treatment

Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the patient's safety or put the study at risk.

Toxicity must have recovered to ≤ Grade 1 from prior chemotherapy (except for alopecia, absolute neutrophil count, and platelet count). (Please refer to Inclusion Criteria 7 and 8 for absolute neutrophil count and platelet count, respectively.)

Unable to swallow capsules, or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.

Prior corticosteroids in excess of prednisone 10 mg/day or its equivalent with antineoplastic intent within 7 days of the start of study drug. Prior chemotherapy, targeted therapy, or radiation therapy within 3 weeks, antineoplastic therapy with Chinese herbal medication or antibody-based therapies within 4 weeks of the start of study drug.

History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention

History of stroke or intracranial hemorrhage within 180 days before first dose of study drug

Major surgery within 4 weeks of the first dose of study drug

Patient requires treatment with warfarin or other vitamin K antagonists

Any contraindication per Tafasitamab United States Prescribing Information (USPI).

Patients with impaired decision-making capacity.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Miami?

Yes, this clinical trial (NCT06029309) has an active research site in Miami, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Mantle Cell Lymphoma Treatment Options in Miami, FL

If you're searching for mantle cell lymphoma treatment options in Miami, FL, this clinical trial (NCT06029309) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Miami research site is actively enrolling participants for this clinical trial. You'll receive care from experienced mantle cell lymphoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all mantle cell lymphoma clinical trials near you to find additional studies recruiting in your area.

Mantle Cell Lymphoma Clinical Trial in Miami, FL

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About This Mantle Cell Lymphoma Study in Miami