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Vinca alkaloids

Marqibo for Acute Lymphoblastic Leukemia

Phase 1
Waitlist Available
Research Sponsored by Therapeutic Advances in Childhood Leukemia Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
-Patients must be ≥ 1 and ≤ 21 years of age at the time of enrollment.
Diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approx. 8 weeks
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat relapsed acute lymphoblastic leukemia.

Eligible Conditions
  • Acute Lymphoblastic Leukemia

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approx. 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and approx. 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Dose Limiting Toxicities as a Measure of Safety and Tolerability
Secondary outcome measures
Therapeutic procedure

Side effects data

From 2016 Phase 2 trial • 175 Patients • NCT01055314
36%
Febrile neutropenia
31%
Death NOS
30%
Diarrhea
22%
Pain
21%
Hyperglycemia
16%
Anorexia
16%
Infections and infestations - Other, specify
16%
Alanine aminotransferase increased
14%
Hypokalemia
13%
Nausea
11%
Hyponatremia
10%
Weight loss
9%
Mucositis oral
9%
Vomiting
9%
Anemia
9%
Aspartate aminotransferase increased
9%
Constipation
9%
Dehydration
9%
Hypophosphatemia
8%
Platelet count decreased
8%
Sepsis
7%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%
Catheter related infection
7%
Colitis
7%
Abdominal pain
6%
White blood cell decreased
6%
Hypotension
6%
GGT increased
6%
Hypocalcemia
6%
Urinary retention
6%
Hypoalbuminemia
6%
Fever
5%
Anxiety
5%
Typhlitis
5%
Neutrophil count decreased
5%
Urinary tract infection
4%
Peripheral motor neuropathy
4%
Enterocolitis
4%
Lipase increased
4%
Pleural effusion
4%
Serum amylase increased
4%
Skin infection
4%
Epistaxis
4%
Urinary tract obstruction
3%
Wound infection
3%
Lymphocyte count decreased
3%
Syncope
3%
Blood bilirubin increased
3%
Dermatitis radiation
3%
Hypertension
3%
Sinus tachycardia
3%
Edema limbs
3%
Bone pain
3%
Dyspnea
3%
Hematuria
3%
Hypercalcemia
2%
Vulval infection
2%
Thromboembolic event
2%
Upper gastrointestinal hemorrhage
2%
Depressed level of consciousness
2%
Stridor
2%
Allergic reaction
2%
Back pain
2%
Lung infection
2%
Urticaria
2%
Acute kidney injury
2%
Muscle weakness lower limb
2%
Musculoskeletal and connective tissue disorder - Other, specify
2%
Pain in extremity
2%
Peripheral sensory neuropathy
2%
Proctitis
2%
Skin ulceration
2%
Apnea
2%
Stoma site infection
2%
Tumor pain
2%
Left ventricular systolic dysfunction
2%
Pancreatitis
2%
Portal hypertension
2%
Rectal hemorrhage
2%
Creatinine increased
2%
Enterocolitis infectious
2%
Hyperkalemia
2%
Investigations - Other, specify
2%
Abdominal distension
1%
Esophageal pain
1%
Heart failure
1%
Gastrointestinal disorders - Other, specify
1%
Hepatobiliary disorders - Other, specify
1%
Penile pain
1%
Menorrhagia
1%
Vascular disorders - Other, specify
1%
Anal hemorrhage
1%
Seizure
1%
Ascites
1%
Anal mucositis
1%
Tracheitis
1%
Vasovagal reaction
1%
Delirium
1%
Bone marrow hypocellular
1%
Sore throat
1%
Anaphylaxis
1%
Soft tissue infection
1%
Fracture
1%
Hydrocephalus
1%
Device related infection
1%
Tooth infection
1%
Gastric ulcer
1%
Sinusitis
1%
Skin and subcutaneous tissue disorders - Other, specify
1%
Pharyngitis
1%
Pyramidal tract syndrome
1%
Anal ulcer
1%
Depression
1%
Ejection fraction decreased
1%
Rash maculo-papular
1%
Pruritus
1%
Myositis
1%
Nail infection
1%
Pain of skin
1%
Pleuritic pain
1%
Pneumonitis
1%
Pneumothorax
1%
Postoperative hemorrhage
1%
Renal and urinary disorders - Other, specify
1%
Respiratory, thoracic and mediastinal disorders - Other, specify
1%
Salivary duct inflammation
1%
Small intestine infection
1%
Alkaline phosphatase increased
1%
Appendicitis
1%
Spinal fracture
1%
Disseminated intravascular coagulation
1%
Ear and labyrinth disorders - Other, specify
1%
Endocrine disorders - Other, specify
1%
Esophageal stenosis
1%
Esophagitis
1%
Gastric hemorrhage
1%
Gum infection
1%
Tumor lysis syndrome
1%
Upper respiratory infection
1%
Hypertriglyceridemia
1%
Hypoxia
1%
Ileus
1%
INR increased
1%
Laryngeal edema
1%
Multi-organ failure
1%
Myelodysplastic syndrome
1%
Oral hemorrhage
1%
Oral pain
1%
Pulmonary edema
1%
Rectal fistula
1%
Rectal pain
1%
Respiratory failure
1%
Bladder spasm
1%
Chest wall pain
1%
Confusion
1%
Congenital, familial and genetic disorders - Other, specify
1%
CPK increased
1%
Dizziness
1%
Encephalopathy
1%
Eye disorders - Other, specify
1%
Generalized muscle weakness
1%
Hoarseness
1%
Hypernatremia
1%
Hypoglycemia
1%
Hypomagnesemia
1%
Insomnia
1%
Irregular menstruation
1%
Irritability
1%
Joint range of motion decreased cervical spine
1%
Kyphosis
1%
Lethargy
1%
Headache
1%
Laryngeal mucositis
1%
Pelvic pain
1%
Esophageal infection
1%
Abdominal infection
1%
Acidosis
1%
Anal fistula
1%
Fall
1%
Fatigue
1%
Gait disturbance
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)
Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort C: Marqibo and maintenance regimenExperimental Treatment1 Intervention
Marqibo®: given by intravenous (IV) infusion on day 1 Dexamethasone orally twice daily on days 1-5 Methotrexate: given orally on days 1 and 8 Mercaptopurine: given orally daily on days 1-13
Group II: Cohort B: Marqibo and lower intensity UK ALL R3 backboneExperimental Treatment1 Intervention
Marqibo®: given by intravenous (IV) infusion on days 1, 8, 15 and 22. Dexamethasone orally twice daily on days 1-5 and 15-19. PEG-asparaginase: given as an injection into the muscle on days 3 and 17. Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8.
Group III: Cohort A: Marqibo and UK ALL R3 backboneExperimental Treatment1 Intervention
Marqibo®: given by intravenous (IV) infusion on days 1, 8, 15 and 22. Dexamethasone orally twice daily on days 1-5 and 15-19. Mitoxantrone: given by intravenous (IV) infusion on days 1 and 2. PEG-asparaginase: given as an injection into the muscle on says 3 and 17. Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vincristine
FDA approved

Find a Location

Who is running the clinical trial?

Therapeutic Advances in Childhood Leukemia ConsortiumLead Sponsor
20 Previous Clinical Trials
641 Total Patients Enrolled
Spectrum Pharmaceuticals, IncIndustry Sponsor
82 Previous Clinical Trials
8,153 Total Patients Enrolled

Frequently Asked Questions

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

What risks are present in the utilization of Marqibo?

"Our internal assessment at Power rates the safety of Marqibo as a 1 due to its early stage clinical trial status, indicating limited data supporting both efficacy and security."

Answered by AI

Is it possible for me to become involved in this medical experiment?

"This clinical investigation has opened its doors to 36 patients between the age of one and 21, who have been diagnosed with acute lymphoblastic leukemia or mixed phenotypic acute leukemia (with ≥ 5% blasts in marrow) or lymphocytic malignancies. Furthermore, participants must have already recovered from any prior chemotherapy, immunotherapy, or radiotherapy-related toxicity up to Grade 2 severity at baseline. Additionally, Karnofsky performance level should exceed 50%, if aged 16+; Lansky capacity needs to be above 50%, for those younger than 16 years old. Moreover, it is essential that all subjects had reached remission before at least"

Answered by AI

Does this research encompass individuals more senior than 35 years of age?

"This research study is searching for participants in the 1-21 age range. Moreover, 591 clinical trials are available to minors and 1321 studies seek seniors as volunteers."

Answered by AI

To what medical ailment is Marqibo commonly administered?

"Marqibo is approved for use in treating idiopathic thrombocytopenic purpura and can also offer relief to those suffering from AIDS, advanced thymoma or small cell lung cancer."

Answered by AI

How widespread is the implementation of this trial's protocol?

"This trial is currently underway at 31 different hospitals, with the Primary Children's Hospital in Salt Lake City, Sidney Kimmel Cancer Center of Johns Hopkins in Baltimore and Levine Children's Hospital in Charlotte being among them."

Answered by AI

What is the highest possible enrollment size for this clinical trial?

"Affirmative. Clinicaltrials.gov data suggests that this clinical trial, which was initially posted on 1/31/2017, is now actively recruiting patients at 31 locations for a total of 36 study participants."

Answered by AI

Are researchers still welcoming participants for this experiment?

"Affirmative. According to the clinicaltrials.gov webpage, this trial is actively seeking participants and was initially published on January 31st 2017 with last alteration occurring on April 15th 2020. 36 individuals are needed across a total of 31 clinics for full enrollment in the study."

Answered by AI

What other research efforts have been conducted concerning Marqibo?

"Currently, Marqibo is being trialled in 232 investigations. Of these studies, 88 are at Phase 3 and 14551 sites offer this medication. Most of the trials for Marqibo occur within New york City limits."

Answered by AI
~4 spots leftby Mar 2025