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Table 4 Mandatory examinations during maintenance therapy

From: Thiopurine Enhanced ALL Maintenance (TEAM): study protocol for a randomized study to evaluate the improvement in disease-free survival by adding very low dose 6-thioguanine to 6-mercaptopurine/methotrexate-based maintenance therapy in pediatric and adult patients (0–45 years) with newly diagnosed B-cell precursor or T-cell acute lymphoblastic leukemia treated according to the intermediate risk-high group of the ALLTogether1 protocol

Maintenance therapy week

 

0

4

8

12

24–36-48-etc

Timeline for standard and experimental arm

Screening

d − 14 to 0

Start MT

d1

2nd cycle MT

d 29

3rd cycle MT

d 57

4th cycle MT

d 85

Every 12 weeks till end of maintenance

Informed consenta

X

     

Medical Historyb

X

X

X

X

 

X

Physical Examination

X

X

X

X

X

X

Height, weight, BSAc

X

X

X

X

  

Vital signsd

X

X

X

X

  

Performance Statuse

X

X

X

X

  

Pregnancy testf

X

 

(X)

(X)

(X)

(X, monthly)

Echocardiogram

Xq

    

X (end of MT)

Eligibility and registrationg

X

     

Concomitant Med

X

X

X

X

X

 

Treatment

 LP with ITh

   

X

 

ALLTogether1

Maintenance therapy

(6MP/MTX/6TG/VCR/DEXA)

 

Continuously

Safety FU

 CBC and differential

X

X

X

X

X

X

 Chemistry panel Ai

X

X

X

X

X

 

 Chemistry panel Bj

     

X

 Amylase, Lipase

X

  

X

  

 Serum Ig levelsk

X

  

X

 

X

 Immunophenotyping of B-cellsl

 

(X)

  

(X)

(X)

 Adverse events

X

X

X

X

X

ALLTogether1

 AESIsm

X

X

X

X

X

X

 6MP/MTX metaboliteso

  

X

X

X

X (monthly)

Efficacy FU

 Disease/survival statusp

 

X

  

X

ALLTogether1

  1. BSA body surface area, CBC complete blood count, ECG electrocardiography, LP lumbar puncture, MRD measurable residual disease, IT intrathecal therapy, ALLTogether1 according to description in ALLTogether1 protocol
  2. a Informed consent must be obtained before any study specific investigations are performed Information can be handed out and consent can be obtained from treatment phase “IR-High Consolidation 2” onwards
  3. b Medical History including review of cancer diagnosis and previous cancer treatment (screening/pre-study visit only), current medications and any current medical conditions or abnormalities
  4. c Calculate BSA \(\left(\sqrt{\frac{\mathrm{Height}\left(\mathrm{cm}\right)\times \mathrm{Weight}\left(\mathrm{kg}\right)}{3600}}\right)\)
  5. d Vital signs include pulse, respirations, blood pressure and temperature
  6. e Performance status, see Additional file 2
  7. f Serum/Urine Pregnancy Test: For patients with child bearing potential, a serum or urine pregnancy test will be performed. If this is not indicated this should be documented in the patient file. Such monthly pregnancy testing must be done until 30 days after the end of maintenance therapy for women of child-bearing potential. Sexually active men must use an effective method of contraception until 90 days efter the end of maintenance therapy
  8. g Online eligibility and registration/ randomization
  9. h Intrathecal therapy will be given as SOC according to the ALLTogether1 protocol
  10. i Chemistry panel A: sodium, potassium, phosphate, creatinine, urea, albumin, total bilirubin (add direct bilirubin when total bilirubin is > UNL), AST, ALT, GGT and alkaline phosphatase
  11. j Chemistry panel B: AST, ALT, total bilirubin (add direct bilirubin when total bilirubin is > UNL), creatinine
  12. k Serum IgG (at screening IgG, IgA IgM)
  13. l Immunophenotyping of B-cells is optional. Standard B cell markers include CD19, CD27, CD38, CD10 as well as stainings for IgM, −G,-A and –D
  14. m AESIs: incidence of > grade 3 infections, IgG levels/administration of IVIG, SOS all grades, ALT and bilirubin > grade 3 are collected from start of maintenance until end of maintenance
  15. o 6TG/6MP/MTX metabolites (Send to Rigshospitalet, Copenhagen Denmark). Samples must be sent at least every 3 months, and are recommended to be sent monthly
  16. p Disease and survival status: Continuous CR, Relapse (including molecular relapse), Second malignant neoplasm, death/cause of death
  17. q Screening echocardiogram can performed during consolidation 3, provided that written informed consent for randomisation R3 has been obtained. When an echocardiogram has been performed after the last dose of doxorubicin in delayed intensification, but before the screening period there is no need to repeat an echocardiogram for screening
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BMC Cancer

ISSN: 1471-2407

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