Is NCT04544592 recruiting in Aurora, CO?

Yes, NCT04544592 is currently recruiting participants at its Aurora, CO location. This b-cell acute lymphoblastic leukemia clinical trial is actively enrolling qualified participants.

How do I join the b-cell acute lymphoblastic leukemia clinical trial in Aurora?

To join this clinical trial in Aurora, 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 Aurora 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.

B-cell Acute Lymphoblastic Leukemia Clinical Trial in Aurora, CO

About This B-cell Acute Lymphoblastic Leukemia Study in Aurora

This phase I/II trial will investigate a new CD19 directed CAR-T therapy manufactured locally with the goals to expedite infusion to wider patient inclusion that includes those who were previously excluded, such as pediatric patients with B-cell NHL and patients in primary relapse.

Sponsor: University of Colorado, Denver

Who Can Participate

Inclusion Criteria

Meets clinical criteria for leukapheresis or has a leukapheresis product previously collected and stored per recommended guidelines.

Provision of signed and dated consent form from parent or guardian (patients \<18), the patient themselves (\>18), or legally authorized representative (patient \>18 who lack decision-making capacity); Pediatric patients will be included in age-appropriate discussions and assent will be obtained for those \> 7 years of age, when appropriate, according to institutional standards.

Willingness to participate in long term follow up study.

Stated willingness to comply with all study procedures and be available for the duration of the study.

Males OR non-pregnant, non-breastfeeding females. o Patients of child-bearing potential or capable of fathering a child must agree to use highly effective contraception from the time of initial CAR T cell administration though 12 months following the final administration of investigational product.

Aged 31 days to 30 years (inclusive) at time of consent and enrollment.

Acute Lymphoblastic Leukemia (ALL) OR Non-Hodgkin Lymphoma (NHL) of B-cell origin that:

Has confirmed expression of CD19 by flow cytometry, immunohistochemistry (IHC), or both. Cohort One Criteria:

Meets any one of the following conditions:

Relapsed two or more times

Relapsed at any time after allogeneic BMT

Refractory to standard therapy as determined by the treating physician

Meets criteria for BMT but is ineligible as determined by the treating physician Patient and/or parents declining BMT options and would prefer CAR-T Therapy.

Non-Hodgkin Lymphoma includes all of the following:

Diffuse large B-cell lymphoma (DLBCL)

Burkitt Lymphoma

Intermediate lymphoma between Burkitt and DLBCL

Primary Mediastinal B-cell Lymphoma (PMBL)

Follicular lymphoma

High grade B cell lymphoma

Transformed lymphoma Cohort Two Criteria:

B-ALL in first relapse with any one of the following conditions:

High-risk genomic alterations at initial diagnosis such as KMT2A gene rearrangement, t(17;19), hypodiploidy, Ph-like mutations, BCR-ABL1 fusion (Ph+ ALL), iAMP21, and TP53 inactivating mutation/deletion.

Isolated CNS relapse such that cranial radiation would be indicated as a component of standard salvage therapy.

Down syndrome.

Minimal residual disease (MRD) positivity of \> 0.01% by FACS or \> 0 clonal sequences by NGS in bone marrow post re-induction chemotherapy.

Age 18 years or older. OR Newly diagnosed with persistent MRD ≥ 0.01% by flow cytometry in bone marrow at end of consolidation.

Performance score (Lansky or Karnofsky) of 50% or better;

Unable to or declined to receive commercially available CD19 CAR-T Therapy.

Exclusion Criteria

Evidence of rapidly progressive disease without adequate salvage/bridging regimens as determined by the investigator.

Active Graft-versus-Host Disease (GvHD).

Active, uncontrolled, life-threatening infection that at the determination of the treating physician would preclude safe leukapheresis or tolerance of LD chemotherapy, cell infusion, or cytokine release syndrome.

Evidence of severe organ dysfunction as defined by:

Myocardial dysfunction: Ejection fraction ≤ 40% or shortening fraction ≤ 28%, evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and clinically significant electrocardiogram (ECG) findings.

Baseline oxygen saturation of ≤ 90% on room air

Transaminases \> 10x upper limit of normal (ULN) or bilirubin \>2x the ULN, unless thought to be related to primary disease

Estimated Cr clearance \<60 mL/min/1.73 m2 (if nuclear medicine GFR or other more specific testing exceeds this level than it can supersede the estimated clearance)

Post-pubertal females that are pregnant, planning to become pregnant, or unwilling to use birth control (includes abstinence) for the study duration.

Known HIV infection, or active Hepatitis B or active Hepatitis C infection.

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 Aurora?

Yes, this clinical trial (NCT04544592) has an active research site in Aurora, CO 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.

B-cell Acute Lymphoblastic Leukemia Treatment Options in Aurora, CO

If you're searching for b-cell acute lymphoblastic leukemia treatment options in Aurora, CO, this clinical trial (NCT04544592) 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 Aurora research site is actively enrolling participants for this clinical trial. You'll receive care from experienced b-cell acute lymphoblastic leukemia 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 b-cell acute lymphoblastic leukemia clinical trials near you to find additional studies recruiting in your area.

B-cell Acute Lymphoblastic Leukemia Clinical Trial in Aurora, CO

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